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
NCT ID: NCT01977534
Last Updated: 2018-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1005 participants
OBSERVATIONAL
2014-01-31
2018-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Absorb BVS
Subjects receiving Absorb BVS
Absorb BVS
The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating \[formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating\].
Interventions
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Absorb BVS
The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating \[formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating\].
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas Baumbach
Role: PRINCIPAL_INVESTIGATOR
Bristol Heart Institute
Susan Veldhof
Role: STUDY_DIRECTOR
Clinical Science
Locations
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Lister Hospital
Stevenage, Hertfordshire, 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
Countries
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References
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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.
Other Identifiers
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13-304
Identifier Type: -
Identifier Source: org_study_id