NCT07368933招募中不适用
ADVANCEd NanoTherapies SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis (ISR) and de Novo Lesions
Advanced NanoTherapies3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Target lesion failure rate (TLF)
研究概览
简要总结
The study objectives are:
- To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease.
- To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions <3.00 mm in diameter in patients with symptomatic coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years or minimum legal age as required by local regulations.
- •Documented stable or unstable angina, positive functional test, or non -ST elevation myocardial infarction which, in the judgment of the operator, is attributable to disease in coronary vessel or in-stent restenosis, and the patient is deemed an appropriate candidate for PCI in accordance with the applicable guidelines on percutaneous coronary intervention.
- •Note: participants with NSTEMI must have enzymes that are trending down or are within normal limits prior to enrollment.
- •Life expectancy >1 year in the Investigator's opinion.
- •Participant is willing and able to cooperate with study procedures and follow-up evaluations.
- •Treatment of only one target lesion required
- •Tandem lesions treated by a single DCB will be considered one target lesion.
- •Up to one de novo lesion in a separate vessel may be treated per standard of care at the procedure. Non-target lesions must be successfully treated under the same criteria of the target lesion, before treating the target lesion.
- •Target lesion must be ≤36 mm in length.
- •Target lesion must have a stenosis ≥ 50% and < 100%.
- •Target lesion must have a visually estimated reference vessel diameter of:
- •ISR lesions: 2.0 to 4.0 mm in diameter (inclusive)
- •de novo lesions: 2.0 to <3.0 mm in diameter
- •ISR lesions only: target lesion must be within a previous BMS or DES that does not extend >5.0 mm beyond the proximal or distal edge.
排除标准
- •Participant is pregnant, or breastfeeding. Note: Participant of childbearing potential must have a negative pregnancy test within 7 days before procedure.
- •Known hypersensitivity or contraindication to antiplatelet medications (e.g., aspirin; heparin; prasugrel); or a sensitivity to contrast media which cannot be adequately pre-medicated.
- •History of an allergic reaction or significant sensitivity to paclitaxel, sirolimus, or any other analogue or derivative.
- •Platelet count < 100,000 cells/mm³ (i.e., 100 x 109 /L) or > 700,000 cells/mm³ (i.e., 700 x 10 9 /L), or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to procedure.
- •Renal insufficiency (Serum creatinine level > 2.5 mg/dl (i.e., 221 μmol/L) within 7 days prior to procedure) or failure (dialysis dependent).
- •Evidence of an acute MI within 72 hours of the procedure Note: participants with NSTEMI are allowed, provided enzymes are trending down or are within normal limits prior to enrollment.
- •Previous PCI of the target vessel within 6 months prior to procedure.
- •History of a stroke or transient ischemic attack (TIA) within the prior 3 months to procedure (any prior stroke or TIA, if prasugrel is used).
- •Planned PCI of any vessel within 30 days post-procedure and/or planned PCI of the target vessel within 12 months post-procedure.
- •Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months to procedure.
- •History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Documented left ventricular ejection fraction (LVEF) <30% at the most recent evaluation, within the prior 3 months to procedure.
- •Planned surgery that would cause interruption in recommended DAPT duration per current guidelines.
- •Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS, or other coronary artery imaging procedures.
- •The following criteria related to previous treatments applies based on the type of lesion treated. The participant is excluded in the following circumstances:
- •ISR lesions: If single-layer ISR, any previous treatment of the target vessel for restenosis. If double- layer ISR, any treatment of the double-layer ISR.
- •de novo lesions: any previous treatment of the target lesion.
- •Planned PCI of three vessel disease during procedure.
- •Planned treatment of more than one target vessel. Tandem lesions that can be treated by a single DCB are permissible.
- •Target lesion requires treatment with atherectomy, laser, or thrombectomy procedure.
- •Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate.
- •Target vessel has evidence of thrombus.
- •Target vessel is excessively tortuous, defined as more than one bend >90° to reach target lesion.
- •Target lesion has any of following characteristics:
- •Lesion location is unprotected in left main coronary artery, internal mammary artery, aorto-ostial, bypass grafts, ostial lesions or within 5 mm of the origin of the left anterior descending or left circumflex.
- •Involves a side branch >2.0 mm in diameter.
- •Is severely calcified.
- •The following criteria based on number and type of lesions:
- •ISR and de novo lesions: target lesion is in the same vessel with a de novo lesion requiring treatment.
- •ISR lesions: planned treatment of a ≥3 layer ISR lesion.
研究组 & 干预措施
SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
Experimental
Subject who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with SirPlux DUO PTCA
干预措施: SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter (Device)
结局指标
主要结局
Target lesion failure rate (TLF)
时间窗: 12 Months
Target lesion failure rate (TLF) at 12 months post-procedure
次要结局
- Performance - Device Sucess(Peri-procedural)
- Performance - Lesion Success(Peri-procedural)
- Performance - Procedural Success(Peri-Procedural through 7 days post-Procedure)
- Late Lumen Loss(6 months post procedure)
- Safety(24 months post procedure)
- Safety(24 Months post-procedure)
研究者
研究点 (3)
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