Safety Study of a Bioresorbable Coronary Stent

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

Detailed Description
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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.

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

Conditions
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Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Disease

Intervention / Treatment
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* Device: ReZolve Stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REVA Medical ReZolve Stent<br>ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent | Device: ReZolve Stent<br>* ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia-driven Target Lesion Revascularization (TLR) | Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QCA & IVUS derived parameters | Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume | 12 months | 
| Major Adverse Coronary Events | 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). | 60 months | 
| Procedural and Technical Success | percentage of patients with angiographic success successful delivery and deployment of the device | Acute |