Trials / Unknown
UnknownNCT01915420
The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions
Postmarketing Surveillance Registry to Monitor Everolimus-eluting Bioresorbable Vascular Scaffold Following Rotational Atherectomy for the Treatment of Complex Coronary Lesions - The ASSURE ROT Registry
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 42 (estimated)
- 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 following rotational atherectomy in patients with complex 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
- 2013-08-01
- Primary completion
- 2015-08-01
- Completion
- 2017-08-01
- First posted
- 2013-08-02
- Last updated
- 2015-02-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01915420. Inclusion in this directory is not an endorsement.