Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT01262703
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2010-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of a Bioresorbable Coronary Stent
Sponsor:
REVA Medical, Inc.
Organization:
Study Overview
Official Title:
Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: