Virtue® SAB in the Treatment of Coronary ISR Trial

Inclusion Criteria:

• In-stent restenosis (one or two stent layers) in a lesion previously treated withdrug- 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 ≤ 4.0mm 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 betreated before the Target Lesion (TL).

• Target lesion length must be ≤ 26 mm and must be completely coverable by only oneVirtue® or AGENT™ balloon. The balloon can extend up to 5 mm proximal or distalbeyond 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 anachieved residual stenosis of ≤ 30% by visual estimate with TIMI grade flow of 3prior to randomization.

Exclusion Criteria:

• Subject has a left ventricular ejection fraction < 30% within 6 months.

• Subject was treated by PCI or another coronary intervention within the last 30 days.

• Planned PCI or CABG after the index procedure.

• Subjects with STEMI < 72 hours prior to index procedure and those with NSTEMI whohave increasing biomarkers within 12 hours of the index procedure.

• If single-layer ISR, any previous treatment (other than balloon angioplasty alone)of the target vessel for restenosis. If double-layer ISR, any treatment (other thanballoon angioplasty alone) of the double-layer ISR restenosis.

• Target lesion is located within a saphenous vein graft or an arterial graft.

• Thrombus is present in the target vessel.

• > 50% stenosis of an additional lesion proximal or clinically significant distal (>2.0mm RVD) to the target lesion.

• A dissection in the target lesion requiring treatment with a stent postpre-dilatation.

• The target ISR lesion has more than two layers of previously placed stents.

• Subject has critical unprotected left main coronary artery disease.