DRKS00031627招募中Unknown
SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI) - SELUTION4BTK Trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 376
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Clinical Inclusion Criteria
- •1. Subject age is = 18 years or older depending on local regulations.
- •2. Subject life expectancy is = 1 year.
- •3. Subject has documented CLTI in the target limb with Rutherford
- •classification category 4 or 5 and symptoms of > 2 weeks duration.
- •4. Subject is willing and able to provide written informed consent and comply
- •with study procedures and required follow-up evaluations.
- •5. Female subjects of childbearing potential must be non-breastfeeding and
- •have a negative pregnancy test = 7 days before the procedure.
- •Angiographic Inclusion Criteria
- •1. Target lesion(s) must be de novo or non-stented restenotic lesion(s) located
- •within the BTK arteries distal to the tibial plateau and above the tibiotalar
- •joint line. BTK arteries include the P3 segment of the popliteal artery, the
- •tibio-peroneal trunk, peroneal artery, anterior tibial artery, and posterior
- •tibial artery.
- •2. BTK Target lesions cannot be contiguous with inflow lesions and at least 3
- •cm of normal artery should extend beyond the tibial plateau to ensure there
- •is no overlap.
- •3. Target lesions must have a diameter stenosis of = 70% (including total
- •occlusions) by visual estimate and must be indicated for PTA treatment.
- •4. Target vessel reference diameter(s) are = 2mm and = 4mm. Note: the
- •SELUTION SLR 014 DEB and the control PTA balloon size cannot exceed 4.0
- •5. Target lesions must be confined to a single target vessel. NOTE: Subjects
- •with other non-target BTK lesions in separate non-target vessels may be
- •enrolled, provided that the non-target lesions have been successfully treated
- •(residual stenosis = 30% with no distal embolization or flow limiting = Grade
- •C dissection). NOTE: Any adjunctive therapies are permitted for the
- •treatment of non-target BTK lesions, but no DEB or DES may be used.
- •6. Any target lesion must be = 30 mm in length and the total combined length
- •of all target lesions must be = 140 mm (total treatment length = 150 mm
- •allowing for 5 mm proximal and distal shoulder treatment). Note: All target
- •lesions and all inflow lesions must be treatable by one or more SELUTION
- •SLR 014/018 DEB(s) such that the total planned per-subject drug dose
- •(calculated by summing the drug dose of all individual planned balloon sizes)
- •would be = 7069 µg. Note: A total treated segment length of = 150 mm for
- •BTK and = 200 mm for inflow segment is acceptable irrespective of DEB
- •balloon diameter.
- •7. The tibial and pedal runoff distal to the target lesions must be patent OR the
- •target vessel(s) must reconstitute above the ankle or display normal terminal
- •branching as follows:
- •a) If the target vessel is the P3 segment, any 1 of the 3 distal arteries must
- •show a patent (= 50% stenosis by visual estimate) outflow.
- •b) If the target vessel is the peroneal artery, the artery must demonstrate
- •normal terminal branching.
- •c) If the target vessel is the anterior tibial (AT) or posterior tibial (PT) artery, the
- •artery must reconstitute = 1 cm above the tibiotalar joint to provide an intact
- •runoff vessel (AT: dorsalis pedis; PT: plantar artery).
- •d) If the target vessel is the tibio-peroneal trunk, outflow for either the
- •peroneal OR the posterior tibial artery must be patent (= 50% stenosis by
- •visual estimate).
- 另有 1 项未显示
排除标准
- •Clinical Exclusion Criteria
- •1. Subject has extensive tissue loss (Rutherford category 6) extending above the
- •trans metatarsal level, salvageable only with complex foot reconstruction or
- •non-traditional trans metatarsal amputations. This includes subjects with:
- •a) Osteomyelitis involving proximal to the metatarsal head(s)
- •b) Any heel wound or wound with calcaneal bone involvement
- •d) Wounds that would require flap coverage or complex wound management
- •for large soft tissue defect
- •e) Full-thickness wounds on the dorsum of the foot with exposed tendon or
- •2. Subject has chronic renal insufficiency (dialysis dependent, or glomerular
- •filtration rate [GFR] = 30 ml/min/1.73 m2 within 30 days of index procedure)
- •or has undergone renal transplantation.
- •3. Subject has acute renal insufficiency confirmed by 50% increase of serum
- •creatinine within 48 hours before procedure and/or decrease in urine output.
- •4. Subject has acute limb ischemia with onset of index limb symptoms less
- •than 2 weeks prior to index procedure.
- •5. Subjects has wounds that are deemed to be neuropathic or non-ischemic in
- •nature or any venous or mixed wounds.
- •6. Subject has had prior major amputation of the ipsilateral extremity or
- •planned major amputation of either leg.
- •7. Target limb iliac or common femoral artery bypass within 6 weeks of index
- •8. Prior (within 14 days) or planned (within 30 days) surgical or endovascular
- •procedures. The following procedures are permitted:
- •a. Target limb inflow treatment at the index procedure, provided it meets the
- •criteria in Angiographic Inclusion Criteria #12
- •b. Contralateral limb iliac artery treatment
- •c. Diagnostic angiography
- •d. Foot wound debridement
- •e. Planned minor amputation of digit(s) at the phalangeal level
- •9. Target lesion has undergone prior DCB within 1 year, or ANY prior DES or
- •bare metal stent (BMS) treatment (no in-stent restenosis [ISR] treatment is
- •permitted). Note: Prior stent is permitted if the target lesion is located = 30
- •mm from the stent AND there is = 30% in-stent diameter stenosis.
- •10. Target lesion(s) requires treatment with alternative therapies such as
- •thrombolysis, thrombus aspiration, stenting, cryoplasty, brachytherapy, or
- •re-entry device. Note: The following adjunctive lesion preparation therapies
- •are permitted: Atherectomy (rotational, orbital, directional or laser),
- •cutting/scoring/contoured balloon, or intravascular lithotripsy.
- •11. Target lesion requires treatment via pedal access or upper extremity access.
- •12. Subject has undergone non-coronary artery treatment with any limus-
- •based drug coated balloon (DCB) or DES or other device within 3 months
- •prior to index procedure.
- •13. Subject has known hypersensitivity or allergy to Sirolimus or other
- •pharmacologic agents required for the procedure (such as contrast agent,
- •heparin, bivalirudin) that cannot be adequately pre-treated.
- •14. Subject has contraindication to antiplatelet therapy.
- •15. Subject has experienced disabling stroke or ST-segment elevation
- •myocardial infarction (STEMI) within 3 months of index procedure.
- •16. Subject has acute coronary syndrome. Stabilized Acute Coronary Syndrome
- •(ACS) is permitted.
- 另有 2 项未显示
研究者
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