NCT07733076尚未招募不适用
A Preliminary Study to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
Shanghai Zhongshan Hospital0 个研究点目标入组 15 人开始时间: 2026年9月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Primary patency rate at 6 months postoperatively
研究概览
简要总结
Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Adults aged ≥18 and ≤80 years, inclusive;
- •2.Patients evaluated by the investigative staff as requiring infra-renal arterial bypass or arterial replacement, including but not limited to: ischemia, infection, trauma, arterial rupture;
- •3.For ischemic limbs requiring infra-inguinal arterial bypass, Rutherford stage 3-6; Ankle-Brachial Index (ABI) ≤0.6; Preoperative imaging showing at least one below-knee artery vessel patent to the ankle with good runoff; No whole-segment healthy great saphenous vein available;
- •4.Patients who are able to communicate effectively with investigative staff, competent and willing to give written informed consent, and are able to comply with entire study procedures including all scheduled follow-up visits.
排除标准
- •1.Distal target artery diameter <2.5mm;
- •2.Known or suspected allergy to contrast media, anticoagulant/antiplatelet drugs, alcohol, or bovine-derived products;
- •3.Hemoglobin <60g/L, platelet count <60×10⁹/L;
- •4.Left ventricular ejection fraction <30%;
- •5.Severe cardiac disease: including New York Heart Association (NYHA) Scale III-IV severe heart failure, or a history of myocardial infarction, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina within 3 months;
- •6.Stroke within 3 months prior to study entry;
- •7.Uncontrolled or poorly controlled diabetes (preoperative glycated hemoglobin >10%);
- •8.Active inflammatory vascular disease;
- •9.Patients with autoimmune diseases or currently receiving immunosuppressive drug therapy;
- •10.Active malignancy or other severe systemic disease with life expectancy less than 12 months;
- •11.History of heparin-induced thrombocytopenia type II (HIT-II) or other contraindications to heparin use;
- •12.AST or ALT >2× the upper limit of normal;
- •13.Coagulation abnormalities (APTT or PT >1.5× upper limit of normal);
- •14.Severe psychiatric disorders that interfere with study compliance;
- •15.Pregnant or breastfeeding female, intending to become pregnancy, or could not use a highly effective method of birth control during the study period;
- •16.Patients in another drug or medical device clinical trials has not yet been enrolled before enrollment;
- •17.There are other factors that deemed unsuitable for study participation by the investigator.
研究组 & 干预措施
LineMatrix® Biological Vascular Graft
Experimental
干预措施: LineMatrix® Biological Vascular Graft (Device)
结局指标
主要结局
Primary patency rate at 6 months postoperatively
时间窗: 6 Months
Defined as: the proportion of vascular graft patency without additional intervention.
次要结局
- Primary patency rate at 3 months and 12 months postoperatively(3-12 Months)
- Cumulative patency rate at 3 months, 6 months, and 12 months(3-12 Months)
- Amputation-free survival rate at 6 months postoperatively(6 Months)
- Limb salvage rate at 6 months postoperatively(6 Months)
- Surgical success rate(1 Month)
- Performance evaluation of biological vascular graft(12 Months)
研究者
相似试验
招募中
不适用
Intervascular Post-Market Clinical Follow-Up (PMCF) RegistryNCT07322913Intervascular1,200
招募中
不适用
Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AMLAMLNCT07490288Institute of Hematology & Blood Diseases Hospital, China27
尚未招募
不适用
Acute or Subacute Iliofemoral Vein Thrombosis: Aspiration for Flow Restoration Versus Standard AnticoagulationNCT07573618Weiwei Wu104
已完成
3 期
Efficacy and Safety of VasoClip® vs. WeckClip® for Robotic Urologic SurgeryNCT07413120Incheon St.Mary's Hospital40
尚未招募
不适用
Study to check the safety and effect of a skin care product on dark spots and skin tone.CTRI/2025/10/096541AU Naturel Beauty Pvt. Ltd (NEUDE).36