NCT02942966已完成不适用
Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 95
- 主要终点
- Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days
研究概览
简要总结
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.
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
- •Males or non-pregnant females ≥ 18 years of age at the time of consent
- •Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception (abstinence is acceptable) through the duration of the study
- •Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the informed consent form (ICF), an impartial witness may sign on behalf of the subject
- •Willing to comply with all required follow-up visits
- •Rutherford Classification 4 or
- •WIfI Wound grade of 0, 1 or modified
- •WIfI Foot Infection grade of 0 or
- •Estimated life expectancy ≥1 year
排除标准
- •Is pregnant or refuses to use contraception through the duration of the study
- •Previous bypass graft in the target limb
- •Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure
- •Prior or planned above-ankle amputation or complete transmetatarsal amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridements)
- •WIfI Foot Infection grade 2 or 3
- •Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12,000/or febrile state
- •Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb less than 30 days prior to or planned for less than 30 days after the index procedure
- •Existing stent implant in the target vessel
- •Any other endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) less than 14 days prior to the index procedure or planned procedure less than 30 days after the index procedure
- •Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter
- •WIfI Wound grade of 2 or
- •Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
- •Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the Index Procedure
- •History of stroke or transient ischemic attack (TIA) less than 90 days prior to the Index Procedure
- •Currently on dialysis
- •Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
- •Participating in another ongoing investigational clinical trial in which the subject has not completed the primary endpoint(s)
- •Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments
- •Known hypersensitivity or allergy to contrast agents that cannot be medically managed
- •Subject already enrolled into this study
- •Restenotic target lesion previously treated by means other than plain balloon angioplasty and/or less than 1 year prior to index procedure.
结局指标
主要结局
Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days
时间窗: 6 months
Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
Safety - Number of Participants With MALE Plus POD at 30 Days
时间窗: 30 days
Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
次要结局
- Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months(6 months)
- Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months(6 months)
研究者
研究点 (95)
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