Coronary Artery Disease, Coronary Artery Stenosis
Conditions
Brief summary
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.
Interventions
DEVICEReZolve2 Scaffold
Sponsors
REVA Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE) | 6 Months |
| Major Adverse Cardiac Events | 12 Months |
| Late Lumen Loss | 9 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TVR | 12,24,36,48 & 60 Months | Target Vessel Revascularization |
| TVF | 12, 24, 36, 48 & 60 Month | Target Vessel Failure |
| QCA derived parameters | 9 Months | Late Loss, Restenosis Rate, % Diameter Stenosis & Minimum Lumen Diameter |
| Acute Technical Success | Day 0 | The percentage of patients with successful delivery and deployment of the scaffold in the intended lesion without device related complications. |
| Clinical Procedural Success | 30 Days | The percentage of patients meeting the Acute Procedural Success criteria with no occurrence of a MACE event through 30 days. |
| Acute Procedural Success | Day 0 | 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. |
| Major Adverse Coronary Events | 24, 36, 48 & 60 Months | Major Adverse Coronary Events - Combined events consisting of death, myocardial infarction and Target Lesion Revascularization |
| TLR | 12,24,36,48 & 60 Months | Target Lesion Revascularization |
Countries
Australia, Brazil, Germany
Outcome results
None listed