Virtue® SAB in the Treatment of Coronary ISR Trial

Inclusion Criteria

• •In-stent restenosis (one or two stent layers) in a lesion previously treated with drug- eluting (DES) or bare metal stents (BMS) in a native coronary artery.
• •The target lesion is in a vessel with a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment.
• •The subject has only one critical ISR lesion.
• •The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL).
• •Target lesion length must be ≤ 26 mm and must be completely coverable by only one Virtue® or AGENT™ balloon. The balloon can extend up to 5 mm proximal or distal beyond the edge of the target stented length.
• •The target lesion must have one of the following:
• •Visually estimated stenosis of ≥ 70% and \<100% diameter stenosis, OR
• •Visually estimated stenosis ≥ 50% and \< 70% with one of the following:
• •abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or;
• •abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or;
• •abnormal stress or imaging stress test, or;
• •ischemic symptoms referable to the target lesion
• •Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes
• •Target lesion must be successfully pre-treated according to standard of care with an achieved residual stenosis of ≤ 30% by visual estimate with TIMI grade flow of 3 prior to randomization.