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).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 740
- 试验地点
- 17
- 主要终点
- Target Lesion Failure (TLF) at 12 months
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Virtue SAB
Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)
干预措施: Virtue Sirolimus AngioInfusion Balloon (Device)
AGENT™ DCB
Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB)
干预措施: AGENT™ Paclitaxel Drug-Coated Balloon (Device)
结局指标
主要结局
Target Lesion Failure (TLF) at 12 months
时间窗: 12 months
Defined as a composite of cardiac death (CD), non-fatal target vessel myocardial infarction (MI) SCAI definition, and ischema-driven target lesion revascularization (TLR)
次要结局
- Target Lesion Failure (TLF) Comparison at 12 months(12 months)