RESTORE: Safety Study of a Bioresorbable Coronary Stent

Sponsor

REVA Medical, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01262703

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Cardiovascular Disease	Device: ReZolve Stent	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent

Actual Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: REVA Medical ReZolve Stent ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent	Device: ReZolve Stent ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Arm

Intervention/Treatment

Experimental: REVA Medical ReZolve Stent

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Device: ReZolve Stent

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Outcome Measures

Primary Outcome Measures

Ischemia-driven Target Lesion Revascularization (TLR) [6 months]
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 [12 months]
Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume
Major Adverse Coronary Events [60 months]
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 [Acute]
percentage of patients with angiographic success successful delivery and deployment of the device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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