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

NCT01977534 | Completed DMC

• 1 other identifier: 13-304
• Study Type: observational
• Target: 1,005
• Locations: 1 country
• Sites: 24

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.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

Bioabsorbable; Coronary Stent; Everolimus; drug eluting stents; stents; angioplasty; coronary artery disease; total coronary occlusion; coronary artery restenosis; stent thrombosis; vascular disease; myocardial ischemia; coronary artery stenosis; CAD; CAOD

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (1)

• Acute Procedural Analyses (all patients)

  During the implantation procedure

Study Arms (1)

Absorb BVS

Subjects receiving Absorb BVS

Device: Absorb BVS

Interventions

Absorb BVS DEVICE

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

Absorb BVS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the general interventional cardiology population

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (24)

Lister Hospital

Stevenage, Hertfordshire, United Kingdom

Location

Basildon Hospital

Basildon, United Kingdom

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

Glan Clwyd District General Hospital

Bodelwyddan, United Kingdom

Location

Royal Bournmouth Hospital

Bournemouth, United Kingdom

Location

Sussex Cardiac Centre

Brighton, United Kingdom

Location

Bristol Heart Institute

Bristol, United Kingdom

Location

Papworth Hospital

Cambridge, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Frimley Park Hospital

Frimley, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Glenfield Hospital

Leicester, United Kingdom

Location

Barts Heart Centre

London, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Northwick Park Hospital

London, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

The Freeman Hospital

Newcastle, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29131802 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Andreas Baumbach

  Bristol Heart Institute

  PRINCIPAL INVESTIGATOR

• Susan Veldhof

  Clinical Science

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 6, 2013
• Study Start: January 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

GB (24)