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

Completed

• Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis
• Interventions: Device: Absorb BVS

• Registration Number: NCT01977534
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Study Start: 2014-01
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1005

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Absorb BVS	Absorb BVS	Subjects receiving Absorb BVS

Primary Outcome Measures

Name	Time	Method
Death (Cardiovascular, Non-Cardiovascular)	3 year
Myocardial Infarction (MI)	1 year	Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)
Target Vessel Revascularization (TVR)	1 year	all TVR
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))	3 year
MI	3 year	Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)
Scaffold/Stent Thrombosis	3 year	Definite, Probable
TVR	3 year	ID-TVR
Acute Success: Device success (lesion based analysis)	From the start of index procedure to end of index procedure	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.
Target Lesion Revascularization (TLR)	1 year	all TLR
Acute Success: Procedural success (patient based analysis)	From the start of index procedure to end of index procedure	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.
TLR	3 year	ID-TLR
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)	3 year
Cardiac Death/All MI/ID-TLR (MACE)	3 year

Trial Locations

Locations (24)

Basildon Hospital; 🇬🇧 Basildon, United Kingdom

Glan Clwyd District General Hospital; 🇬🇧 Bodelwyddan, 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

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

The Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Norfolk & Norwich University Hospital; 🇬🇧 Norwich, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Lister Hospital; 🇬🇧 Stevenage, Hertfordshire, United Kingdom

Royal Bournmouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom