This trial is active, not recruiting.

Conditions coronary artery disease, coronary artery stenosis
Treatment rezolve2 scaffold
Sponsor REVA Medical, Inc.
Start date April 2013
End date September 2014
Trial size 125 participants
Trial identifier NCT01845311, HCT4000


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
rezolve2 scaffold

Primary Outcomes

Major Adverse Cardiac Events (MACE)
time frame: 6 Months
Major Adverse Cardiac Events
time frame: 12 Months
Late Lumen Loss
time frame: 9 Months

Secondary Outcomes

QCA derived parameters
time frame: 9 Months
Major Adverse Coronary Events
time frame: 24, 36, 48 & 60 Months
time frame: 12,24,36,48 & 60 Months
time frame: 12,24,36,48 & 60 Months
time frame: 12, 24, 36, 48 & 60 Month
Acute Procedural Success
time frame: Day 0
Acute Technical Success
time frame: Day 0
Clinical Procedural Success
time frame: 30 Days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold
Principal investigator Alexandre Abizaid, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by REVA Medical, Inc..