Trials / Unknown
UnknownNCT02486068
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,670 (actual)
- Sponsor
- European Cardiovascular Research Center · Network
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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 target lesion failure (TLF) at 1 year * To assess superiority of the BRS to the EES in TLF between 3 and 7 years
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ABSORB scaffold | |
| DEVICE | Xience |
Timeline
- Start date
- 2015-09-28
- Primary completion
- 2018-08-28
- Completion
- 2024-09-01
- First posted
- 2015-07-01
- Last updated
- 2018-08-14
Locations
44 sites across 9 countries: Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02486068. Inclusion in this directory is not an endorsement.