Status:
COMPLETED
ReZolve2 Clinical Investigation
Lead Sponsor:
REVA Medical, Inc.
Conditions:
Coronary Artery Disease
Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.
Eligibility Criteria
Inclusion
- Primary
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01845311
Start Date
April 1 2013
End Date
January 1 2019
Last Update
March 29 2023
Active Locations (3)
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1
St Vincent's Hospital
Sydney, Australia
2
Instituto Dante Pazzanese de Cariologia
São Paulo, Brazil
3
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany