Virtue® SAB in the Treatment of Coronary ISR Trial

A Prospective, Multi-center, Single-blind, Randomized (1:1), Non-inferiority Study Comparing Clinical Outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the Treatment of Coronary Artery In-stent Restenosis (ISR).

A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).

The Virtue® ISR trial is a prospective, multi-center, single-blind, randomized (1:1), non-inferiority study. The Virtue® Sirolimus AngioInfusion™ Balloon (SAB) will be compared to the AGENT Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).

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 has a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment.
• The subject has only one critical ISR lesion in the target vessel.
• 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.

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 who have 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 than balloon 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 post pre-dilatation.
• The target ISR lesion has more than two layers of previously placed stents.
• Subject has critical unprotected left main coronary artery disease.