ReZolve2 Clinical Investigation

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

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

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