Clinical trial NCT01977534: 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
Official title: A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 1005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the general interventional cardiology population

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Acute Success: Device success (lesion based analysis)
timeFrame: From the start of index procedure to end of index procedure
measure: Acute Success: Procedural success (patient based analysis)
timeFrame: From the start of index procedure to end of index procedure
measure: Death (Cardiovascular, Non-Cardiovascular)
timeFrame: 1 year
measure: Death (Cardiovascular, Non-Cardiovascular)
timeFrame: 3 year
measure: Myocardial Infarction (MI)
timeFrame: 1 year
measure: MI
timeFrame: 3 year
measure: Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: TLR
timeFrame: 3 year
measure: TLR
timeFrame: 1 year
measure: TLR
timeFrame: 3 year
measure: Target Vessel Revascularization (TVR)
timeFrame: 1 year
measure: TVR
timeFrame: 3 year
measure: TVR
timeFrame: 1 year
measure: TVR
timeFrame: 3 year
measure: Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
timeFrame: 1 year
measure: Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
timeFrame: 3 year
measure: Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 1 year
measure: Cardiac Death/All MI/ID-TLR (MACE)
timeFrame: 3 year
measure: Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
timeFrame: 1 year
measure: Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
timeFrame: 3 year
measure: Scaffold/Stent Thrombosis
timeFrame: 1 year
measure: Scaffold/Stent Thrombosis
timeFrame: 1 year
measure: Scaffold/Stent Thrombosis
timeFrame: 3 year
measure: Scaffold/Stent Thrombosis
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
measure: Acute Procedural Analyses (all patients)
timeFrame: During the implantation procedure
Locations:
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: Hertfordshire
city: Basildon
country: United Kingdom
facility: Basildon Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Bodelwyddan
country: United Kingdom
facility: Glan Clwyd District General Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournmouth Hospital
city: Brighton
country: United Kingdom
facility: Sussex Cardiac Centre
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: Barts Heart Centre
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle
country: United Kingdom
facility: The Freeman Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Bristol Heart Institute
name: Andreas Baumbach
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Science
name: Susan Veldhof
role: STUDY_DIRECTOR
References:
citation: 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.