ReZolve2 Clinical Investigation

Study Overview
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Brief Summary
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The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.

Official Title
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RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold

Conditions
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Coronary Artery Disease, Coronary Artery Stenosis

Intervention / Treatment
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* Device: ReZolve2 Scaffold


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Patient has evidence of myocardial ischemia or a positive functional study Patient has a normal CK-MB Target lesion has a visually estimated stenosis of ≥50% and <100% Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.75mm and ≤ 3.3mm Target lesion length must be ≤ 14mm Primary Exclusion Criteria: Patient has experienced a myocardial infarction (CK-MB or Troponin > 5 X ULN) within 72 hours of the procedure Patient has a left ventricular ejection fraction < 30% Patient has unprotected lest main coronary disease with ≥50% stenosis The target vessel is totally occluded (TIMI Flow 0 or 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 bypass 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: ReZolve2 Treatment Group<br> | Device: ReZolve2 Scaffold<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) |  | 6 Months | 
| Major Adverse Cardiac Events |  | 12 Months | 
| Late Lumen Loss |  | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QCA derived parameters | Late Loss, Restenosis Rate, % Diameter Stenosis & Minimum Lumen Diameter | 9 Months | 
| Major Adverse Coronary Events | Major Adverse Coronary Events - Combined events consisting of death, myocardial infarction and Target Lesion Revascularization | 24, 36, 48 & 60 Months | 
| TLR | Target Lesion Revascularization | 12,24,36,48 & 60 Months | 
| TVR | Target Vessel Revascularization | 12,24,36,48 & 60 Months | 
| TVF | Target Vessel Failure | 12, 24, 36, 48 & 60 Month | 
| Acute Procedural Success | The percentage of patients meeting the Acute Technical Success criteria and the procedure results in a residual stenosis of <50 percent with no immediate (in-hospital) MACE. | Day 0 | 
| Acute Technical Success | The percentage of patients with successful delivery and deployment of the scaffold in the intended lesion without device related complications. | Day 0 | 
| Clinical Procedural Success | The percentage of patients meeting the Acute Procedural Success criteria with no occurrence of a MACE event through 30 days. | 30 Days |