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 (ABSORB UK)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Disease; Coronary Restenosis
• Intervention / Treatment: Device: Absorb BVS

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 Type: Observational
• Enrollment (Actual): 1005

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the general interventional cardiology population

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Absorb BVS; Subjects receiving Absorb BVS	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].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Death (Cardiovascular, Non-Cardiovascular)		1 year
Death (Cardiovascular, Non-Cardiovascular)		3 year
Myocardial Infarction (MI)	Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)	1 year
MI	Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)	3 year
Target Lesion Revascularization (TLR)	all TLR	1 year
TLR	all TLR	3 year
TLR	clinically indicated (ID-TLR)	1 year
TLR	ID-TLR	3 year
Target Vessel Revascularization (TVR)	all TVR	1 year
TVR	all TVR	3 year
TVR	clinically indicated (ID-TVR)	1 year
TVR	ID-TVR	3 year
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)		1 year
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)		3 year
Cardiac Death/All MI/ID-TLR (MACE)		1 year
Cardiac Death/All MI/ID-TLR (MACE)		3 year
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))		1 year
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))		3 year
Scaffold/Stent Thrombosis	acute, sub-acute, late and very late	1 year
Scaffold/Stent Thrombosis	Definite, Probable	1 year
Scaffold/Stent Thrombosis	acute, sub-acute, late and very late	3 year
Scaffold/Stent Thrombosis	Definite, Probable	3 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 parametersCASS numbersNo. 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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Andreas Baumbach, Bristol Heart Institute; Study Director: Susan Veldhof, Clinical Science

Publications and helpful links

General Publications

• Baumbach A, Zaman A, West NEJ, O'Kane P, Egred M, Johnson T, Wheatcroft S, Bowles R, de Belder A, Bouras G, Lansky A, Hill J, Mathur A, de Belder MA, Banning AP. Acute and one-year clinical outcomes following implantation of bioresorbable vascular scaffolds: the ABSORB UK Registry. EuroIntervention. 2018 Jan 20;13(13):1554-1560. doi: 10.4244/EIJ-D-17-00886.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimate): November 6, 2013

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: coronary artery disease; Everolimus; stents; angioplasty; drug eluting stents; CAD; stent thrombosis; Bioabsorbable; Coronary Stent; myocardial ischemia; vascular disease; total coronary occlusion; coronary artery restenosis; coronary artery stenosis; CAOD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Restenosis
• Other Study ID Numbers: 13-304