NCT06214247已完成不适用
A Prospective, Open Label, Multi-center, Randomized Study Designed to Evaluate the Safety and Efficacy of Scoring PTCA Catheter on Subjects During Percutaneous Coronary Intervention
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 11
- 主要终点
- Procedure Success Rate
研究概览
简要总结
To evaluate the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter for dilating coronary stenosis during PCI in comparison with a similar product on the market.
详细描述
The prospective, multicenter, open-label, randomized clinical study is designed to verify the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter in the application of dilatating coronary artery stenosis during PCI in comparison with a similar product on the market. The study is planned to enroll 198 subjects, who are randomly assigned to the test group (99 cases) and the control group (99 cases).
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
- Double (Participant, 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
- •Age≥18 years old.
- •Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, stable / unstable angina or silent ischemia.
- •Subjects with coronary artery stenosis confirmed by imaging examination are suitable for percutaneous coronary intervention (PCI).
- •Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
- •Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
- •Target lesion with reference vessel diameter (RVD) of 2.0mm - 4.0mm, length ≤30mm (by visual inspection).
- •Only one lesion will be selected as the target lesion for revascularization when subjects have multiple lesions requiring treatment. Tandem lesions (defined as multiple lesions) are deemed one lesion if they can be covered by a single stent.
- •If target lesions and non-target lesions are treated simultaneously, they must be located in different coronary artery from the Target lesion
排除标准
- •Subjects with bleeding tendency, contraindications to antiplatelet agent and anticoagulant therapy, and inability to anticoagulant therapy.
- •Subjects are sensitivity to contrast media which cannot be adequately pre-medicated.
- •Subjects with severe renal failure, whether on dialysis or not, with a glomerular filtration rate (eGFR) level < 30ml/min/1.73m2 or serum creatinine level> 2.0 mg/dl within 7 days prior to index procedure.
- •Subjects with decompensated congestive heart failure or cardiogenic shock.
- •Subjects with expected life less than 12 months.
- •Subjects with an active peptic ulcer or active gastrointestinal bleeding within 1 month prior to index procedure.
- •Subjects with an embolic stroke or transient ischemic attack within 2 months prior to index procedure.
- •Subject with known pregnancy or is nursing. Women of child-bearing potential shall undertake a pregnancy test before index procedure.
- •Subjects enrolled in any other clinical trial within 1 month prior to the trial or currently.
- •Subjects who have poor compliance and cannot complete the trial as required.
- •Lesions with total coronary artery occlusion (TIMI 0 or 1).
- •Severe calcifications (grade Ⅲ-Ⅳ) or extreme angulation (>90°), etc., and lesions are inability to pass the study balloon or stent.
- •Lesions with visible thrombosis or ulcers.
- •Lesions with significant intima tears.
- •Unprotected left main disease.
- •Lesions located within an artery/saphenous vein graft or graft anastomosis.
- •Coronary artery spasm without significant stenosis.
- •Saphenous vein graft degenerative disease
- •Other situations that the investigator considers inappropriate for participation in this trial.
结局指标
主要结局
Procedure Success Rate
时间窗: before discharge or within 3 days after the procedure
Procedure success is defined as the target lesion residual stenosis ≤30% right after PCI, without death, Q-wave or non-Q-wave myocardial infarction, or emergency coronary artery bypass grafting (CABG) during postoperative hospitalization.
次要结局
- Minimum Luminal Diameter (MLD)(Immediately after procedure)
- Device Procedural Success Rate(Immediately after procedure)
- Acute Lumen Gain (ALG)(Immediately after procedure)
- Balloon Slippage Rate(Immediately after procedure)
- Clinical Success Rate(30-day follow-up after procedure)
- Percent of Diameter Stenosis(%DS)(Immediately after procedure)
- Surgical complication(Day 0)
- Rate of Adverse Events(Month 3)
研究者
研究点 (11)
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