Overview

This trial is active, not recruiting.

Conditions myocardial ischemia, coronary artery stenosis, coronary disease, coronary artery disease, coronary restenosis, cardiovascular disease
Treatment rezolve stent
Sponsor REVA Medical, Inc.
Start date December 2011
End date September 2014
Trial size 50 participants
Trial identifier NCT01262703, HCT1000

Summary

To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
rezolve stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Primary Outcomes

Measure
Ischemia-driven Target Lesion Revascularization (TLR)
time frame: 6 months

Secondary Outcomes

Measure
QCA & IVUS derived parameters
time frame: 12 months
Major Adverse Coronary Events
time frame: 60 months
Procedural and Technical Success
time frame: Acute

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent
Principal investigator Alexandre Abizaid, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by REVA Medical, Inc..