ABSORB EXTEND Clinical Investigation

Coronary Artery Disease Clinical Trial

— ABSORB EXTEND  

Official title:

ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023789
• Other study ID #: 09-386
• Secondary ID: ACTRN12610000131
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: January 18, 2018
• Start date: January 2010
• Est. completion date: October 2016

Study information

• Verified date: December 2017
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System

ABSORB BVS is currently in development at Abbott Vascular.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.

• Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is = 2.0 mm and = 3.3 mm and target lesion length is = 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).

• Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of = 50% and < 100% with a TIMI flow of = 1.

• If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).

• Percutaneous interventions for lesions in a non-target vessel are allowed if done = 30 days prior to or if planned to be done 6 months after the index procedure.

• Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.

Exclusion Criteria:

• Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.

• Lesion(s) involving a bifurcation with side branch vessel = 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.

• Total occlusion (TIMI flow 0), prior to wire passing.

• Target vessel(s) contains visible thrombus.

• Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).

• Subject has received brachytherapy in any epicardial vessel (including side branches).

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

Locations

Country	Name	City	State
Argentina	Instituto Cardiovascular de Buenos Aires-ICBA	Buenos Aires
Australia	Wesley Hospital	Auchenflower	Queensland
Australia	Monash Medical Center	Melbourne	Victoria
Australia	St. Vincent's Hospital	Melbourne	Victoria
Australia	Eastern Heart Clinic, The Prince of Wales Hospital	Randwick	New South Wales
Austria	Allgemeines Krankenhaus Linz	Linz
Belgium	Onze-Lieve VrouweZiekenhuis	Aalst
Brazil	Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia	Sao Paulo
Brazil	Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein	Sao Paulo
Brazil	Instituto Coração Triângulo Mineiro	Uberlandia
Canada	Montreal Heart Institute	Montreal
Canada	University of Ottawa Heart Institute	Ottawa
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec
Canada	St. Michael's Hospital	Toronto
China	Prince of Wales Hospital	Hong Kong
China	Queen Mary Hospital	Hong Kong
Denmark	Århus University Hospital	Århus N
France	Institut Jacques Cartier (ICPS)	Massy
France	Clinique Pasteur	Toulouse
France	Hopital De Rangueil - CHU	Toulouse
Germany	Charité Berlin Campus Steglitz	Berlin
Germany	Uni.Klinikum Heidelberg	Heidelberg
India	Care Institute of Medical Sciences	Ahmedabad
India	SAL Hospital And Medical Institute	Ahmedabad
India	Madras Medical Mission	Chennai
India	Medanta -The Medicity	Gurgaon
India	Apollo Hospital	Hyderabaad	Andhar Pradesh
India	CARE Hospital	Hyderabaad	Andhra Pradesh
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow
India	Escorts Heart Institute & Research Centre	New Delhi
Israel	Rabin Medical Center	Petah Tikva
Italy	Catanzaro University Hospital	Catanzaro
Italy	Centro Cardiologico Monzino	Milano
Japan	Mitsui Memorial Hospital	Chiyoda-ku
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Kyoto University Hospital	Kyoto	Kansai
Japan	Teikyo University	Tokyo	Itabashi
Japan	Saiseikai Yokohama City Eastern Hospital	Yokohama	Kanagawa
Malaysia	Institute Jantung Negara	Kuala Lumpur
Netherlands	Catharina ZH Eindhoven	Eindhoven
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Maasstad Ziekenhuis	Rotterdam
New Zealand	Mercy Angiography Unit	Auckland
New Zealand	Christchurch Hospital	Christchurch
Poland	University Hospital Krakow	Krakow
Singapore	National University Hospital	Singapore
South Africa	Sunninghill Hospital	Johannesburg
Spain	Clinico San Carlos	Madrid
Spain	La Paz	Madrid
Spain	Hospital do Meixoeiro	Pontevedra
Sweden	Lund University Hospital	Lund
Switzerland	Inselspital Bern, Kardiologie	Bern
Taiwan	Chang Gung Memorial Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Denmark,  France,  Germany,  India,  Israel,  Italy,  Japan,  Malaysia,  Netherlands,  New Zealand,  Poland,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)	The composite endpoint composed of; Cardiac death,; Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),; Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).	= 7 days post index procedure (In hospital)
Primary	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)	The composite endpoint composed of; Cardiac death,; Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),; Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.	0 to 30 days
Primary	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).	0 to 180 days
Primary	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).	0 to 1 year
Secondary	Clinical Device Success	Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.	On day 0 (immediate post-index procedure)
Secondary	Clinical Procedure Success	Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.	On day 0 (immediate post-index procedure)
Secondary	Number of Participants With Cardiac Death	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	= 7 days post index procedure (In-hospital )
Secondary	Number of Participants With Myocardial Infarction (MI) - Per Protocol	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	= 7 days post index procedure (In-hospital )
Secondary	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	= 7 days post index procedure (In-hospital )
Secondary	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	= 7 days post index procedure (In-hospital )
Secondary	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		= 7 days post index procedure (In-hospital )
Secondary	Number of Participants With Cardiac Death	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	0 to 30 days
Secondary	Number of Participants With Myocardial Infarction (MI) - Per Protocol	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 30 days
Secondary	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 30 days
Secondary	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 30 days
Secondary	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		0 to 30 days
Secondary	Number of Participants With Cardiac Death	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	0 to 180 days
Secondary	Number of Participants With Myocardial Infarction (MI) - Per Protocol	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 180 days
Secondary	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 180 days
Secondary	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 180 days
Secondary	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		0 to 180 days
Secondary	Number of Participants With Cardiac Death	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	0 to 1 year
Secondary	Number of Participants With Myocardial Infarction (MI) - Per Protocol	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 1 year
Secondary	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 1 year
Secondary	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 1 year
Secondary	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		0 to 1 year
Secondary	Number of Participants With Cardiac Death	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	0 to 2 year
Secondary	Number of Participants With Myocardial Infarction (MI) - Per Protocol	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 2 year
Secondary	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 2 year
Secondary	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 2 year
Secondary	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		0 to 2 year
Secondary	Number of Participants With Cardiac Death	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	0 to 3 years
Secondary	Number of Participants With Myocardial Infarction (MI) - Per Protocol	Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves	0 to 3 years
Secondary	Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)	Revascularization at the target lesion associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 3 years
Secondary	Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)	Revascularization in the target vessel associated with any of the following: Positive functional ischemia study.; Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).; Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.	0 to 3 years
Secondary	Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		0 to 3 years
Secondary	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)	The composite endpoint composed of; Cardiac death,; Myocardial infarction (Q wave and Non-Q wave),; Ischemia-driven target vessel revascularization by CABG or PCI.	= 7 days post index procedure (In hospital)
Secondary	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)	The composite endpoint composed of; Cardiac death,; Myocardial infarction (Q wave and Non-Q wave),; Ischemia-driven target vessel revascularization by CABG or PCI.	0 to 30 days
Secondary	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)	The composite endpoint composed of; Cardiac death,; Myocardial infarction (Q wave and Non-Q wave),; Ischemia-driven target vessel revascularization by CABG or PCI.	0 to 180 days
Secondary	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)	The composite endpoint composed of; Cardiac death,; Myocardial infarction (Q wave and Non-Q wave),; Ischemia-driven target vessel revascularization by CABG or PCI.	0 to 1 year
Secondary	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)	The composite endpoint composed of; Cardiac death,; Myocardial infarction (Q wave and Non-Q wave),; Ischemia-driven target vessel revascularization by CABG or PCI.	0 to 2 years
Secondary	Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)	The composite endpoint composed of; Cardiac death,; Myocardial infarction (Q wave and Non-Q wave),; Ischemia-driven target vessel revascularization by CABG or PCI.	0 to 3 years
Secondary	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).	0 to 2 years
Secondary	Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).	0 to 3 years
Secondary	Number of Participants With Scaffold Thrombosis (Early)	According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation; *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).; †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.	0 to 30 days
Secondary	Number of Participants With Scaffold Thrombosis	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation; *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).; †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.	0 to 180 days
Secondary	Number of Participants With Scaffold Thrombosis (Late)	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation; *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).; †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.	31 - 365 days
Secondary	Number of Participants With Scaffold Thrombosis	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation; *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).; †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.	0 to 1 year
Secondary	Number of Participants With Scaffold Thrombosis (Very Late)	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation; *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).; †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.	366 days to 2 years
Secondary	Number of Participants With Scaffold Thrombosis	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation; *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).; †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.	0 to 2 years
Secondary	Number of Participants With Scaffold Thrombosis	According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.; Timing: Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation; *Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).; †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.	0 to 3 years
Secondary	Area Stenosis (%)		18 months
Secondary	Minimum Lumen Area		18 months
Secondary	Mean Vessel Area		18 months
Secondary	Minimum Vessel Area		18 months
Secondary	Maximum Vessel Area		18 months
Secondary	Mean Lumen Area		18 months
Secondary	Maximum Lumen Area		18 months
Secondary	Mean Plaque Area		18 months
Secondary	Minimum Plaque Area		18 months
Secondary	Maximum Plaque Area		18 months
Secondary	Mean Reference Area		18 months
Secondary	Calculated Minimum Lumen Diameter	The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.	18 months
Secondary	Calculated Diameter Stenosis	The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).	18 months