Trials / Completed
CompletedNCT01262703
Safety Study of a Bioresorbable Coronary Stent
Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- REVA Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
Detailed description
Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.
Conditions
- Myocardial Ischemia
- Coronary Artery Stenosis
- Coronary Disease
- Coronary Artery Disease
- Coronary Restenosis
- Cardiovascular Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ReZolve Stent | ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2013-10-01
- Completion
- 2018-12-01
- First posted
- 2010-12-17
- Last updated
- 2023-03-29
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01262703. Inclusion in this directory is not an endorsement.