Trials / Completed
CompletedNCT01583608
ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease
ABSORB: Initial Clinical Experience With the Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) System in the Treatment of de Novo Native Coronary Artery Lesions - a Surveillance Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 183 (actual)
- Sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery lesions in all-day clinical practice.
Detailed description
Bioresorbable scaffolds are transient implants. They act like drug-eluting metallic stents (DES) during the first 3 months by supporting the vessel wall thereby keeping the artery patent. Subsequently, resorption of the scaffold begins and its structure loosens. As a result of everolimus release, neointimal growth is inhibited similar to DES. Finally the implant is reabsorbed completely in about 2-3 years. BVS in terms of late stent thrombosis may be safer than DES. Transiently scaffolded vessels may regain their natural curvature and angulation as well as response to nitroglycerine and endothelial function.
Conditions
- Cardiovascular Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Coronary Restenosis
- Heart Diseases
- Coronary Stenosis
- Arteriosclerosis
- Arterial Occlusive Diseases
- Vascular Diseases
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2013-03-01
- Completion
- 2016-06-01
- First posted
- 2012-04-24
- Last updated
- 2016-12-09
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01583608. Inclusion in this directory is not an endorsement.