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that must be treated before the Target Lesion (TL).\n* 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.\n* The target lesion must have one of the following:\n* Visually estimated stenosis of ≥ 70% and \\\u003C100% diameter stenosis, OR\n* Visually estimated stenosis ≥ 50% and \\\u003C 70% with one of the following:\n* abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or;\n* abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or;\n* abnormal stress or imaging stress test, or;\n* ischemic symptoms referable to the target lesion\n* Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes\n* 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.\n\nExclusion Criteria:\n\n* Subject has a left ventricular ejection fraction \\\u003C 30% within 6 months.\n* Subject was treated by PCI or another coronary intervention within the last 30 days.\n* Planned PCI or CABG after the index procedure.\n* Subjects with STEMI \\\u003C 72 hours prior to index procedure and those with NSTEMI who have increasing biomarkers within 12 hours of the index procedure.\n* 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.\n* Target lesion is located within a saphenous vein graft or an arterial graft.\n* Thrombus is present in the target vessel.\n* \\> 50% stenosis of an additional lesion proximal or clinically significant distal (\\>2.0mm RVD) to the target lesion.\n* A dissection in the target lesion requiring treatment with a stent post pre-dilatation.\n* The target ISR lesion has more than two layers of previously placed stents.\n* Subject has critical unprotected left main coronary artery disease.","ALL","18 Years",{"count":253,"type":254},740,"ESTIMATED","INTERVENTIONAL",[257],"NA","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).",[260],"Coronary Artery Disease",[262],"In-Stent Restenosis","2026-07-22",{"date":265,"type":266},"2026-07-23","ACTUAL",{"date":268,"type":266},"2025-10-20",{"date":270,"type":254},"2032-10",{"name":5,"class":6},15]