NCT04058990已完成不适用
A 2:1 Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 25
- 主要终点
- Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)
研究概览
简要总结
A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
详细描述
Primary objective is to evaluate the safety and effectiveness of the Agent ™ Paclitaxel-Coated PTCA Balloon Catheter for the treatment of Japanese subjects with a small vessel de novo native atherosclerotic coronary artery lesion or in-stent restenosis (ISR) of a previously treated lesion.
Primary endpoint: Target Lesion Failure (TLF) rate at 6 months post index-procedure. TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
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)
盲法说明
SV study: A prospective, multicenter, 2:1 randomized, controlled, single-blind, non-inferiority trial.150 subjects are expected to be enrolled to support a 2:1 randomization. (Investigational test device: Agent DCB, N=100 subjects or Control device: SeQuent Please DCB, N=50 subjects)
ISR substudy: A prospective, multicenter, single-arm, open-label trial. 30 subjects are expected to be enrolled.
入排标准
- 年龄范围
- 20 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 20 years of age.
- •Subject understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- •Subject is eligible for percutaneous coronary intervention (PCI).
- •Subject has documented stable angina pectoris or unstable angina pectoris. If subject has documented stable angina pectoris, one of the following criteria meet.
- •≥90% diameter stenosis.
- •Stenosis that is considered a cause of stable effort angina (Only when it's without confirmation of significant stenosis).
- •Stenosis that is confirmed a cause of functional ischemia with any test.
- •Subject is an acceptable candidate for coronary artery bypass grafting (CABG).
- •Subject is willing to comply with all protocol-required follow-up evaluation.
- •Patients undergoing first or second treatment for ISR lesions for the non-randomized ISR substudy.
- •The target lesion meets all following criteria.
- •Target lesion length must measure (by visual estimate) ≤28 mm.
- •Target lesion must be a visually estimated reference vessel diameter (RVD) ≥2.00mm and <3.00 mm (This applys for SV trial. For ISR substudy: RVD ≥2.00mm and ≤4.00 mm.).
- •Target lesion must be a de novo lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100% (This applys for SV trial. For ISR substudy: Target lesion for ISR must be in-stent restenosis of a previously-treated lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100%.).
- •Coronary anatomy is likely to allow delivery of an investigational device to the lesions.
- •Target lesion must be successfully pre-dilated.
- •Planned treatment of 2 coronary artery lesions in 2 vessels may be treated (For SV trial, up to two lesions per vessel can be treated. For ISR substudy, single lesion per vessel can be treated.).
排除标准
- •Subject has had an acute myocardial infarction within 72 hours prior to the index procedure.
- •Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina.
- •Subject has severe left ventricular dysfunction with ejection fraction <30%.
- •Subject has received an organ transplant or is on a waiting list for an organ transplant.
- •Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure.
- •Subject has renal failure with a serum creatinine of > 2.0mg/dL or who is receiving dialysis or chronic immunosuppressant therapy.
- •Subjects has one of the following.
- •Not expected to live for the duration of the study (1 year) by investigator's discretion due to other serious medical illness.
- •Current problems with substance abuse.
- •Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
- •Planned PCI (including staged procedures) or CABG after the index procedure.
- •Subject previously treated at any time with intravascular brachytherapy.
- •Subject has a known allergy to contrast and/or the investigational device or protocol-required concomitant medications, iopromide, raw materials of Agent DCB and SeQuent Please DCB, P2Y12 inhibitor or aspirin).
- •Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm
- •Subject has a white blood cell (WBC) count < 3,000 cells/mm
- •Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
- •Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
- •Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
- •Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure.
- •Target vessel has been treated with any type of PCI within 6 months prior to the index procedure.
- •Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment.
- •Non-target vessel has been treated with any type of PCI within 24 hours prior to the index procedure.
- •Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint.
- •Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure.
- •Subject with known intention to procreate within 6 months after the index procedure.
- •Subject is a woman who is pregnant or nursing.
- •Target lesion meets any of the following criteria:
- •Left main location.
- •Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate.
- •> 50% stenosis of an additional lesion proximal or distal to the target lesion (by visual estimate).
- •Located within a saphenous vein graft or an arterial graft.
- •Will be accessed via a saphenous vein graft or an arterial graft.
- •Involves a complex bifurcation (e.g., bifurcations requiring treatment with more than 1 stent).
- •TIMI flow 0 (total occlusion) prior to wire crossing.
- •Excessive tortuosity proximal to or within the lesion.
- •Extreme angulation proximal to or within the lesion.
- •Target lesion and/or target vessel proximal to the lesion is severely calcified by visual estimate to expect sub-optimal balloon expansion.
- •Target lesion and/or target vessel adjacent to the target lesion presents with dissection or aneurysm by visual estimate.
- •Restenosis from previous intervention (This is applicable only to SV trial.).
- •PCI within 10 mm proximal or distal to the target lesion (by visual estimate) at any time prior to the index procedure （This is applicable only to SV trial.）.
- •Planned treatment of a single lesion with more than 1 investigational device.
- •In-stent restenosis due to stent fracture or recoil (This is applicable only to ISR substudy.).
- •Non-target lesion to be treated during the index procedure meets any of the following criteria:
- •Located in the target vessel (This is applicable only to ISR substudy.).
- •Located within a bypass graft (venous or arterial).
- •Left main location.
- •Chronic total occlusion.
- •Involves a complex bifurcation.
- •Located within 15 mm of the proximal or distal shoulder of the target lesion by visual estimate in the case of the same vessel with a target lesion for SV trial.
- 另有 3 项未显示
研究组 & 干预措施
Agent Paclitaxel-Coated PTCA Balloon Catheter
Experimental
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
干预措施: Device: Paclitaxel-Coated PTCA Balloon Catheter (Device)
SeQuent Please Drug Eluting Balloon Catheter
Active Comparator
Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)
干预措施: SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel (Device)
结局指标
主要结局
Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)
时间窗: 6 months post procedure
TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
次要结局
未报告次要终点
研究者
研究点 (25)
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