NCT02151812已完成不适用
A Prospective Randomized Multicenter Non-inferiority Clinical Study to Determine the Safety and Performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter (Hemoteq) Compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter (B.Braun) for the Treatment of Coronary In-Stent Restenosis (AGENT-ISR)
Hemoteq AG24 个研究点 分布在 2 个国家目标入组 123 人开始时间: 2014年8月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 24
- 主要终点
- in-stent late lumen loss
研究概览
简要总结
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis).
The performance will be determined at six months post-procedure by quantitative coronary angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA results will be assessed by an independent, blinded angiographic core lab.
Study statistical hypothesis: The loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the Agent™ study device is not larger than the respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is non-inferior to the control device with respect to LLL.
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 (Outcomes Assessor)
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
- •Subject must be at least 18 years of age
- •Subject is willing and able to provide informed consent
- •Subject is eligible for percutaneous coronary intervention
- •Subject is willing to comply with all protocol-required follow-up evaluations
- •Women of child-bearing potential must agree to use a reliable method of contraception
- •In-stent restenosis in a lesion previously treated with either a drug-eluting or bare metal stent, located in a native coronary artery with a reference vessel diameter ≥ 2.0 mm and ≤ 3.5 mm
- •Target lesion length must be ≤ 28 mm (by visual estimate) and must be covered by only one balloon
- •Target lesion must have visually estimated stenosis ≥ 70% and < 100% in asymptomatic patients
- •Target lesion must have visually estimated stenosis ≥ 50% and < 100% in symptomatic patients
- •Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be ≥ 1
- •Target lesion must be successfully pre-dilated.
排除标准
- •Patient has life expectancy of less than 24 months
- •Patient with known coronary artery spasm
- •Patient with unprotected left main coronary artery disease
- •Patient has current problems with substance abuse
- •Patient has planned procedure that may cause non-compliance with the protocol or confound data interpretation
- •Patient is participating in another investigational drug or device clinical study that has not reached its primary endpoint
- •Patient intends to participate in another investigational drug or device clinical study within 12 months after the index procedure
- •Woman who is pregnant or nursing
- •Left ventricular ejection fraction < 25%
- •Patient had PCI or other coronary interventions within the last 30 days
- •Planned PCI or CABG after the index procedure
- •Patient to receive other PCI interventions in the target vessel, such as rotablation, laser atherectomy, cutting balloon, DCB, DES, BMS, bioabsorbable scaffold etc.
- •Patient to receive DCB in non-target coronary vessels
- •Acute MI < 72h
- •Cardiogenic shock
- •Known allergies against Paclitaxel or other components of the used medical devices
- •Known hypersensitivity or contraindication for contrast dye that cannot be adequately pre-medicated
- •Intolerance to antiplatelet drugs, anticoagulants required for the procedure
- •Platelet count < 100k/mm3 or > 500k/mm3
- •Patient with renal failure with a serum creatinine of > 2.5mg/dL who is receiving dialysis or chronic immunosuppressant therapy
- •Target lesion is located within a bifurcation involving a major side branch > 2 mm in diameter
- •Target lesion is located within a saphenous vein graft or an arterial graft
- •Target lesion with TIMI grade flow = 0 (total occlusion)
- •Thrombus present in the target vessel
- •> 50% stenosis of an additional lesion proximal or distal to the target lesion
结局指标
主要结局
in-stent late lumen loss
时间窗: six months
In-stent late lumen loss (LLL) of the treated stented segment after PTCA using the Agent(TM) study device in comparison to the LLL after PTCA using the SeQuent(R) Please control device as measured by QCA at six months post-index procedure.
次要结局
- Target lesion revascularization (TLR) rate(36 months)
- Target vessel revascularization (TVR) rate(36 months)
- Cardiac, non-cardiac and all death rates(36 months)
- In-segment minimal lumen diameter (MLD)(6 months post-index procedure)
- technical success rate(during index procedure, less 1 hour)
- clinical procedural success rate(within 24 hours of index procedure)
- In-stent percent diameter stenosis(6 months post-index procedure)
- In-stent minimal lumen diameter (MLD)(6 months post-index procedure)
- In-segment percent diameter stenosis(6 months post-index procedure)
- In-stent binary restenosis rate(6 months post-index procedure)
- In-segment binary restenosis rate(6 months post-index procedure)
- In-segment late lumen loss(6 months post-index procedure)
- Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)(36 months)
- Stent thrombosis rate (by ARC definition)(36 months)
- Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)(36 months)
- Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)(36 months)
- Change in Quality of Life(36 months)
研究者
研究点 (24)
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