NCT07159087Enrolling By Invitation不适用
A Multicenter, Prospective, Randomized, Double-blind, Pivotal Clinical Trial to Compare the Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- In-segment late lumen loss after procedure
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of Genoss® SCB by comparing in-segment late lumen loss (LLL) to the control group (SeQuent® Please NEO) at 6 months in patients with coronary stent-in-stent restenosis (ISR) with a reference vessel diameter of 2.0-4.0 mm.
详细描述
This pivotal study is a randomized controlled trial to compare with the control group (SeQuent® Please NEO), and will recruit 94 patients with in-stent restenosis (ISR) from 9 institutions. The test group (Genoss® SCB) and the control group (SeQuent® Please NEO) will be randomly assigned 1:1, and all patients will be followed up at 1, 6, and 12 months after the procedure. The primary endpoint is to evaluate in-segment late lumen loss by quantitative coronary angiography (QCA) by an independent assessor at 6 months after the procedure.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 19 years of age
- •Patients with in-stent restenosis who are candidates for percutaneous coronary intervention (PCI)
- •In cases corresponding to one of the following conditions: non-ST-segment elevation myocardial infarction (NSTEMI), stable angina, unstable angina, or silent myocardial ischemia
- •Women of childbearing potential* must agree to use at least one medically acceptable method of contraception** throughout the duration of the clinical trial
- •Subjects who voluntarily agree to participate and provide written informed consent
- •Subjects who are willing to comply with the requirements of the clinical trial protocol
- •Subjects who develop in-stent restenosis (ISR) ≥ 90 days after the index coronary stent implantation, with the restenosis classified as Mehran type I to III
- •Subjects with a maximum of two ISR lesions, with visually estimated significant coronary artery stenosis on quantitative coronary angiography analysis (QCA) meeting one of the following criteria:
- •In asymptomatic patients: in-segment percent diameter stenosis (DS%) > 70% compared to the reference vessel diameter of the target vessel* (*Target vessel: the vessel containing the target lesion with the minimum lumen diameter.)
- •In patients with angina symptoms or evidence of ischemia on non-invasive functional testing: DS% > 50%
- •On QCA, the ISR lesion(s) to be treated must have a lesion length < 36 mm and the reference vessel diameter (RVD) of the target coronary artery must be between 2.0 mm and 4.0 mm.
排除标准
- •Patients diagnosed with ST-segment elevation myocardial infarction (STEMI) by electrocardiogram.
- •Known hypersensitivity or contraindications at screening to any of the following drugs or substances: Aspirin, Heparin, Clopidogrel, Prasugrel, Ticagrelor, Sirolimus, Paclitaxel, Delivery matrix (e.g., shellac, vitamin E-TPGS), Ticlopidine, Contrast agents (e.g., Iopromide) Note: Subjects with contrast media sensitivity may be enrolled if the reaction is manageable with steroids and pheniramine; however, those with a known anaphylactic reaction are excluded.
- •Subjects who are scheduled for or require surgery within 1 year of the index procedure that would necessitate discontinuation of antiplatelet therapy.
- •Subjects with bleeding disorders, gastrointestinal ulcers, or any conditions that may increase the risk of bleeding, in which anticoagulation is contraindicated or limited.
- •Subjects with a left ventricular ejection fraction (LVEF) < 30% as assessed by echocardiography.
- •Severe renal failure (Creatinine > 2.0 mg/dL) that makes QCA inappropriate.
- •Subjects with cardiogenic shock.
- •Pregnant or breastfeeding women: Women of childbearing potential with a positive urine hCG (or serum β-hCG) test are excluded.
- •Subjects with an estimated life expectancy of less than 1 year due to comorbid conditions.
- •Subjects with medical conditions such as significant psychiatric disorders that may interfere with trial participation or outcomes.
- •Subjects who, in the investigator's opinion, are inappropriate for this clinical trial or for whom participation poses increased risk.
- •Participation in another clinical trial currently or within 90 days prior to screening.
- •Any other condition deemed ethically or clinically inappropriate by the investigator to participate in the study: Specific reasons should be recorded in the Case Report Form (CRF).
- •[Exclusion Criteria Based on QCA and Pre-Dilatation Assessment of ISR Lesions]
- •ISR lesions located in graft vessels following coronary artery bypass grafting (CABG).
- •Presence of coronary stent fracture in the ISR lesion to be treated.
- •Target lesion with two or more stents implanted, i.e., all segments of the target lesion contain ≥2 layers of stents.
- •Presence of additional lesions proximal or clinically significant distal to the target lesion (>2.0 mm RVD) with >50% stenosis.
- •Subjects requiring CABG based on any of the following:
- •Lesions in the left main coronary artery.
- •Triple-vessel coronary artery disease.
- •Other conditions requiring CABG as determined by the investigator.
- •Subjects for whom pre-dilatation is not feasible or has failed, making application of the investigational device difficult due to any of the following:
- •Total occlusion of the target lesion.
- •Evidence of thrombus not treatable with aspiration.
- •Severe vessel tortuosity or calcification preventing access to the target site, as determined by the investigator.
- •Other conditions deemed unsuitable for investigational device application by the investigator.
- •After lesion pre-dilatation, if any of the following are present:
- •Need for atherectomy (rotational, orbital, or laser).
- •Presence of flow-limiting dissection of NHLBI type C or higher requiring stent implantation.
- •Residual stenosis* in the target lesion. (*Defined as in-segment DS > 30%)
- •Fractional flow reserve (FFR) ≤ 0.8 (FFR measurement may be omitted at the discretion of the investigator.)
- •TIMI flow < 3
结局指标
主要结局
In-segment late lumen loss after procedure
时间窗: at 6 months after procedure
In-segment refers to a portion including within 5 mm of each of the distal and proximal portions at the boundary of the inserted stent. Therefore, in-segment late lumen loss (LLL) is defined as the difference (mm) in the minimum lumen diameter (MLD) within the segment at 6 months from baseline.
次要结局
- In-stent late lumen loss after procedure(at 6 months after procedure)
- Target Lesion Failure (TLF), %(at 1 month, 6 months, and 12 months after procedure)
- Patient-oriented composite endpoint (POCE), %(at 1 month, 6 months, and 12 months after procedure)
- Device success rate, %(Immediately after the procedure)
- All-cause death, %(at 1 month, 6 months, 12 months after procedure)
- Ischemia-driven target vessel revascularization (ID-TVR), %(at 1 month, 6 months, and 12 months after procedure)
- Procedural success rate, %(up to 24 hours)
- Cardiac Death, %(at 1 month, 6 months, and 12 months after procedure)
- Target vessel myocardial infarction (TV-MI), %(at 1 month, 6 months, and 12 months after procedure)
- Myocardial infarction (MI), %(at 1 month, 6 months, and 12 months after procedure)
- Binary restenosis rate, %(at 6 months after procdure)
- Ischemia-driven target lesion revascularization (ID-TLR), %(at 1 month, 6 months, and 12 months after procedure)
- Revascularization, %(at 1 month, 6 months, and 12 months after procedure)
- Stent thrombosis(at 1 month, 6 months, and 12 months after procedure)
- Stroke, %(at 1 month, 6 months, and 12 months after procedure)
- Major bleeding BARC type III to V, %(at 1 month, 6 months, and 12 months after procedure)
- Abrupt closure/ Sub abrupt closure, %(at 1 months after procedure)
研究者
研究点 (2)
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