Clinical trials: Bioresorbable Scaffold
Acute ST Segment Elevation Myocardial Infarction
ABSORB STEMI: the TROFI II Study
This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority, European multicenter clinical trial. The primary objective of this study is to assess the neointimal healing score (as evaluated by…
- Trial name
- NCT01986803
- Testing
- Percutaneous Coronary Intervention
- Where
- 8 sites in Denmark, Netherlands and 2 more
- Volunteers
- 191 people
- Sponsor
- ECRI bv
Coronary Artery Lesion
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
The primary objectives of this trial are: In patients at high-risk for restenosis, To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in…
- Trial name
- Compare Absorb (NCT02486068)
- Testing
- ABSORB scaffold, Xience
- Where
- 44 sites in Belgium, Czechia and 7 more
- Volunteers
- 1,670 people
- Sponsor
- European Cardiovascular Research Center
Coronary Artery Disease, Stable Angina
Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis
The aim of the study is to investigate if lesion preparation with a ScoreFlex balloon compared to a standard non-compliant balloon improve vascular healing and minimize lumen reduction after implantation of a Magmaris…
- Conditions
- Coronary Artery Disease, Stable Angina, Coronary Artery Stenosis, Myocardial Infarction
- Trial name
- OPTIMIS (NCT04666584)
- Testing
- ScoreFlex balloon, Device: standard non-compliant balloon
- Where
- Denmark
- Volunteers
- 82 people
- Sponsor
- Odense University Hospital
Vulnerable Plaque
Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold
The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS)…
- Trial name
- NCT02319733
- Testing
- Bioresorbable vascular scaffold
- Where
- Netherlands
- Volunteers
- 1 people
- Sponsor
- Canisius-Wilhelmina Hospital
Coronary Artery Stenosis
Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system in patients suffering from coronary artery…
- Trial name
- GABI-R (NCT02066623)
- Testing
- ABSORB Scaffold
- Where
- 81 sites in Austria, Germany
- Volunteers
- 3,330 people
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
Myocardial Ischemia, Coronary Artery Stenosis
ABSORB EXTEND Clinical Investigation
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- ABSORB EXTEND (NCT01023789)
- Testing
- ABSORB BVS
- Where
- 56 sites in Argentina, Australia and 23 more
- Volunteers
- 812 people
- Sponsor
- Abbott Medical Devices