To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels

Coronary Artery Disease Clinical Trial

— ABSORB UK  

Official title:

A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977534
• Other study ID #: 13-304
• Status: Completed
• Start date: January 2014
• Est. completion date: October 2018

Study information

• Verified date: December 2018
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.

Description:

ABSORB UK registry is a prospective, single arm, post-market registry designed to:

• Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).

• Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1005
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:

• Patient must be at least 18 years of age at the time of signing the Informed Consent Form

• Patient is to be treated for de novo lesions located in previously untreated vessels.

• Patient must agree to undergo all required follow-up visits and data collection.

Exclusion Criteria:

The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:

• Inability to obtain a signed informed consent from potential patient.

• Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).

Related Conditions & MeSH terms

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

Intervention

Device:
• Absorb BVS
The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating].

Locations

Country	Name	City	State
United Kingdom	Basildon Hospital	Basildon
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Glan Clwyd District General Hospital	Bodelwyddan
United Kingdom	Royal Bournmouth Hospital	Bournemouth
United Kingdom	Sussex Cardiac Centre	Brighton
United Kingdom	Bristol Heart Institute	Bristol
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Frimley Park Hospital	Frimley
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	Barts Heart Centre	London
United Kingdom	Kings College Hospital	London
United Kingdom	Northwick Park Hospital	London
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	The Freeman Hospital	Newcastle
United Kingdom	Norfolk & Norwich University Hospital	Norwich
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Lister Hospital	Stevenage	Hertfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Procedural Analyses (all patients)	Access site (femoral, brachial, radial); Lesion preparation (Lesion 1, 2, 3, etc.); Balloon pre-dilatation (yes - Max balloon size/Max balloon pressure, Cutting balloon yes/no, Other yes/no); Techniques used to adequately prepare the lesion (de-calcification techniques (Rotablator yes/no, Other yes/no)); Treatment parameters; CASS numbers; No. of scaffolds per analyzable lesion (Lesion 1, 2, 3, etc.); Scaffold length (Lesion 1, Lesion 2, Lesion 3, etc.); Lesion length (Lesion 1, Lesion 2, Lesion 3, etc.); Bailout / bailout device (if bailout required); Post-treatment of lesion?; Balloon post-dilatation (no, yes - Max balloon diameter/Max balloon pressures/balloon length); Jailed side-branch (no, yes). If yes, treatment of jailed sidebranch? (no, yes)	During the implantation procedure
Primary	Acute Success: Device success (lesion based analysis)	Achievement of a final in-scaffold residual diameter stenosis of < 50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device is considered to have failed if it did not meet the requirements of the definition for clinical device success.	From the start of index procedure to end of index procedure
Primary	Acute Success: Procedural success (patient based analysis)	Achievement of a final in-scaffold diameter stenosis of < 50% by online QCA or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.	From the start of index procedure to end of index procedure
Primary	Death (Cardiovascular, Non-Cardiovascular)		1 year
Primary	Death (Cardiovascular, Non-Cardiovascular)		3 year
Primary	Myocardial Infarction (MI)	Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)	1 year
Primary	MI	Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)	3 year
Primary	Target Lesion Revascularization (TLR)	all TLR	1 year
Primary	TLR	all TLR	3 year
Primary	TLR	clinically indicated (ID-TLR)	1 year
Primary	TLR	ID-TLR	3 year
Primary	Target Vessel Revascularization (TVR)	all TVR	1 year
Primary	TVR	all TVR	3 year
Primary	TVR	clinically indicated (ID-TVR)	1 year
Primary	TVR	ID-TVR	3 year
Primary	Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)		1 year
Primary	Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)		3 year
Primary	Cardiac Death/All MI/ID-TLR (MACE)		1 year
Primary	Cardiac Death/All MI/ID-TLR (MACE)		3 year
Primary	Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))		1 year
Primary	Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))		3 year
Primary	Scaffold/Stent Thrombosis	acute, sub-acute, late and very late	1 year
Primary	Scaffold/Stent Thrombosis	Definite, Probable	1 year
Primary	Scaffold/Stent Thrombosis	acute, sub-acute, late and very late	3 year
Primary	Scaffold/Stent Thrombosis	Definite, Probable	3 year