Safety Study of a Bioresorbable Coronary Stent (RESTORE)

REVA Medical

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Restenosis; Coronary Artery Stenosis; Coronary Disease; Cardiovascular Disease

Treatments: Device: ReZolve Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262703

HCT1000

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

REVA Medical ReZolve Stent

Experimental group

Description:

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Treatment:

Device: ReZolve Stent