Safety Study of a Bioresorbable Coronary Stent (RESTORE)
This study is currently recruiting participants.
Verified June 2012 by REVA Medical, Inc.
Sponsor:
REVA Medical, Inc.
Information provided by (Responsible Party):
REVA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01262703
First received: December 16, 2010
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
| Condition | Intervention |
|---|---|
|
Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Cardiovascular Disease |
Device: ReZolve Stent |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent |
Resource links provided by NLM:
Further study details as provided by REVA Medical, Inc.:
Primary Outcome Measures:
- Ischemia-driven Target Lesion Revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Secondary Outcome Measures:
- QCA & IVUS derived parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume
- Major Adverse Coronary Events [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]Major Adverse Cardiac Events - Combined events consisting of death, Myocardial Infarction (Q-Wave, Non Q-wave: CPK > 2xULN + MB>ULN) (MI), and target vessel revascularization (TVR).
- Procedural and Technical Success [ Time Frame: Acute ] [ Designated as safety issue: Yes ]percentage of patients with angiographic success successful delivery and deployment of the device
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: REVA Medical ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
|
Device: ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Evidence of myocardial ischemia or a positive functional study.
- Normal CK-MB.
- Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS
- Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 2.
- Staged procedures are allowed in non-target vessels >24 hours before or > 30 days after REVA stent implantation
Exclusion Criteria:
- A myocardial infarction (CK-MB or Troponin > 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus
- Unprotected left main coronary disease with >50% stenosis
- The target vessel is totally occluded (TIMI Flow 0 to 1)
- Target lesion involves a bifurcation (a lesion with a side branch >2.0 mm in diameter containing a >50% stenosis)
- Target lesion is located within a segment supplied by distal graft
- Target lesion has possible or definite thrombus
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262703
Contacts
| Contact: Alexandre Abizaid, MD | aabizaid@uol.com.br |
Locations
| Brazil | |
| Instituto Dante Pazzanese de Cardiologia | Recruiting |
| Sao Paulo, Brazil | |
| Contact: Alexandre Abizaid, MD | |
Sponsors and Collaborators
REVA Medical, Inc.
Investigators
| Principal Investigator: | Alexandre Abizaid, MD | Instituto Dante Pazzanese de Cardiologia |
More Information
No publications provided
| Responsible Party: | REVA Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01262703 History of Changes |
| Other Study ID Numbers: | HCT1000 |
| Study First Received: | December 16, 2010 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency (Anvisa) Germany: Federal Institute for Drugs and Medicinal Devices (BfArM) |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Ischemia Coronary Stenosis Coronary Restenosis Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
Sirolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013