SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)

Coronary Artery Disease Clinical Trial

Official title:

SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171820
• Other study ID #: 05-369 Diabetic Sub-study
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2010
• Last updated: October 1, 2010
• Start date: November 2006
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).

Description:

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.

The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years

• able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site

• diagnosed with diabetes, as documented by medical history.

• evidence of myocardial ischemia

• acceptable candidate for CABG surgery

• agree to undergo all CIP-required follow-up examinations

• artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents

• maximum of one, de novo, target lesion per native major epicardial vessel or side branch

• target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate

• target lesion = 28 mm in length by visual estimate

• target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1

Exclusion Criteria:

• known diagnosis of AMI within 72 hours preceding the index procedure

• current unstable arrhythmias

• LVEF < 30%

• received a heart or any other organ transplant or is on a waiting list for any organ transplant

• receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.

• receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease

• known hypersensitivity or contraindication to specific agents

• elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel

• platelet count limits, WBC limits or documented or suspected liver disease

• renal insufficiency

• history of bleeding diathesis or coagulopathy or will refuse blood transfusions

• CVA or TIA within the past 6 months

• significant GI or urinary bleed within the past 6 months

• history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)

Target lesion meets any of the following criteria:

• In-stent restenotic

• aorto-ostial location (within 3 mm)

• left main location

• located within 2 mm of the origin of the LAD or LCX

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

• lesion involving a side branch = 2.5 mm in diameter

• lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation

• located in a major epicardial vessel that has been previously treated with brachytherapy

• located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure

• total occlusion (TIMI flow 0), prior to wire crossing

• excessive tortuosity proximal to or within the lesion

• extreme angulation (= 90%) proximal to or within the lesion

• heavy calcification

The target vessel contains visible thrombus

Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)

Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• TAXUS® Liberté™
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
• XIENCE V® EECSS
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes

Locations

Country	Name	City	State
Austria	Salzburger Landeskliniken	Salzburg
France	C.H.U. - Hopital Michallon	Grenoble
France	CHU Lille - Hôpital Cardiologique	Lille
Germany	Herzzentrum	Bernau
Germany	Universitätsklinikum	Heidelberg
Germany	Lukas Krankenhaus Neuss	Neuss
Germany	Herzzentrum Siegburg GmbH	Siegburg
Israel	Sheba Medical Center	Ramat Gan
Italy	Azienda Ospedaliera Riuniti	Bergamo
Italy	Ospedale Civile	Mirano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera S. Gdi Dio Salerno	Salerno
Malaysia	Institute Jantung Negara	Kuala Lumpur
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Maasstad Ziekenhuis	Rotterdam
Poland	Medical University of Bydgoszcz	Bydgoszcz
Spain	General De Alicante	Alicante
Spain	Hospital Belvigte de Barcelona	Barcelona
Spain	Hospital Santa Creu I Sant Pau	Barcelona
Spain	Clinico San Carlos	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	La Paz	Madrid
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital General de Valencia	Valencia
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
United Kingdom	King's College Hospital	London
United Kingdom	Wessex Cardiac Unit	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Austria,  France,  Germany,  Israel,  Italy,  Malaysia,  Netherlands,  Poland,  Spain,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent Late Loss(LL)	In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up	270 days	No
Secondary	Clinical Device Success	Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.	Acute: At time of index procedure	No
Secondary	Clinical Procedure Success	Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.	Acute: At time of index procedure	Yes
Secondary	In-segment Late Loss	In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up	270 days	No
Secondary	Proximal Late Loss	Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up	270 day	No
Secondary	Distal Late Loss	Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up	270 days	No
Secondary	In-stent Angiographic Binary Restenosis Rate	Percent of patients with a follow-up percent diameter stenosis of = 50% per Quantitative Coronary Angiogram.	270 days	No
Secondary	In-segment Angiographic Binary Restenosis Rate	Percent of patients with a follow-up percent diameter stenosis of = 50% per Quantitative Coronary Angiogram.	270 days	No
Secondary	In-stent Percent Diameter Stenosis	This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.; This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiogram.	270 days	No
Secondary	In-segment Percent Diameter Stenosis	This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.; This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiogram.	270 days	No
Secondary	Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)	A thrombosis is blood clot that forms on the stent. This outcome measures the percentage of participants found to have this condition.	30 days	Yes
Secondary	Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)	A thrombosis is blood clot that forms on the stent	240 days	Yes
Secondary	Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)	A thrombosis is blood clot that forms on the stent	1 year	Yes
Secondary	Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.		30 days	Yes
Secondary	Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.		240 days	Yes
Secondary	Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.		1 year	Yes
Secondary	Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)		30 days	Yes
Secondary	Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)		240 days	Yes
Secondary	Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)		1 year	Yes
Secondary	Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR)		30 days	Yes
Secondary	Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR)		240 days	Yes
Secondary	Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR)		1 year	Yes
Secondary	Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)		30 days	Yes
Secondary	Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)		240 days	Yes
Secondary	Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)		1 year	Yes

External Links

•   SPIRIT V registry arm