NL-OMON56385尚未招募不适用
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) - SELUTION SLR 014 BTK study
M.A. Med Alliance SA0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 chronic limb-threatening ischemia in the target limb
- •with Rutherford classification category 4, 5 or 6 and symptoms of > 2 weeks
- •4. Subject is willing and able to provide written informed consent and comply
- •with study procedures and required follow-up evaluations.
- •5. Female subjects only: If female, then subjects of childbearing potential
- •must be non-breastfeeding and have a negative pregnancy test <= 7 days before
- •the procedure and be prepared to use effective contraception for 24 months
- •after treatment.
- •ANGIOGRAPHIC INCLUSION CRITERIA
- •1. Target lesion(s) must lie distal to the tibial plateau and above the
- •tibiotalar joint line within the BTK arteries. There is no limitation on total
- •target lesion length. Two in-line areas of stenosis are considered multiple
- •lesions if a) there is 2 cm of normal appearing artery between them, and b) at
- •least 1 cm of the normal appearing artery is not treated. Otherwise, the
- •lesions should be considered a single lesion and the entire segment should be
- •treated with the assigned devices. If multiple SELUTION* SLR DEB are used, the
- •total allowable drug dose per patient by summing the drug dose per individual
- •balloons must be <= 4396µg.
- •2. Distal tibial and pedal runoff for each target lesion treated is patent
- •(defined as <50% stenosis of the associated distal tibial artery and pedal
- •outflow arteries).
- •3. Target vessel reference diameter(s) are >= 2mm and <= 4mm.
- •4. Arterial inflow (ipsilateral common iliac, external iliac, common femoral
- •and profunda femoris arteries, SFA and popliteal artery proximal to the tibial
- •plateau) is free from >= 50% stenosis as confirmed on angiography.
- •a) If >= 50% inflow stenosis of the common and external iliac, superficial
- •femoral, and proximal popliteal arteries is found, it must be successfully
- •treated during the index procedure.
- •b) Completion angiography must confirm successful treatment of inflow disease
- •(<=30% residual stenosis, no distal embolization, and no Grade C or greater
- •dissection ) prior to pre-dilation and randomization of the BTK target
- •5. Successful pre-dilatation (defined by <= 30% residual stenosis, no distal
- •embolization, and no Grade C or greater dissection) of all target lesions with
- •uncoated PTA catheter sized to the reference vessel diameter must be
- •accomplished before randomization.
排除标准
- •CLINICAL EXCLUSION CRITERIA
- •1. Subject underwent failed POBA intervention on the target lesion(s) within 3
- •months of the index procedure.
- •2. Subject underwent surgical or endovascular procedure within 14 days prior to
- •index procedure, or is planned for surgical or endovascular procedure within 30
- •days following index procedure, with the exception of:
- •a) Diagnostic angiography prior to index procedure
- •b) Treatment of contralateral iliac disease and/or treatment of inflow disease
- •of the index limb that is completed prior to randomization
- •c) Planned amputation of digit(s) of the index limb at the phalangeal level
- •d) Debridement of a foot wound
- •3. Subject has infrainguinal disease in the contralateral leg that requires
- •treatment at the index procedure, or treatment planned to occur within 14 days
- •prior to the index procedure or within 30 days after the index procedure.
- •4. Subject is planned to undergo major amputation of either leg.
- •5. Subject has undergone any prior major amputation of the ipsilateral
- •6. Subject is unable to tolerate dual antiplatelet therapy.
- •7. Subject has undergone non-coronary artery treatment with any limus based
- •drug-coated or drug-eluting balloon/stent/other device within one year prior to
- •index procedure.
- •8. Subject has undergone prior DCB, DES or BMS treatment of current target
- •9. Subject has known hypersensitivity or allergy to Sirolimus or other
- •pharmacologic agents (such as contrast agent, heparin, bivalirudin) required
- •for the procedure, and this hypersensitivity/allergy cannot be adequately
- •pre-treated.
- •10. Subject has experienced stroke or MI within 3 months of index procedure.
- •11. Subject had onset of index limb symptoms less than 14 days prior to index
- •procedure (acute limb ischemia).
- •12. Subject has undergone prior bypass of arteries of the index limb (except
- •for iliac artery bypass).
- •13. Subject has non-atherosclerotic disease of the index limb (including
- •aneurysmal disease, vasculitis, Buerger*s disease)
- •14. Subject has target lesion(s) that require (pre-)treatment with alternative
- •therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured
- •balloon, stenting, laser, cryoplasty, brachytherapy, intravascular lithotripsy,
- •or re-entry device.
- •15. Subject has target lesion(s) that require treatment via pedal site.
- •16. Subject has target lesion(s) that require access via upper extremity
- •17. Subject has extensive tissue loss salvageable only with complex foot
- •reconstruction or non-traditional trans metatarsal amputations. This includes
- •subjects with:
- •a) Osteomyelitis involving, more proximal to, the metatarsal head(s)
- •b) Any heel wound or wound with calcaneal bone involvement
- •c) Wounds that are deemed to be neuropathic or non-ischemic in nature
- •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 bone
- •f) Venous or mixed wounds.
- •18. Subject has hypercoagulable state or disorder, or coagulopathy, including
- •platelet count less than 100,000 per microliter.
- 另有 4 项未显示
研究者
相似试验
招募中
不适用
A Prospective Randomized single blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR* 014 Drug Eluting Balloon in the Treatment of Subjects with In-stent Restenosisin-stent restenosisreocclusion of coronary vessels10011082NL-OMON54574MedAlliance LLC40
招募中
1 期
A prospective randomized single blind multicenter phase II study of organ perfusion with Custodiol-N compared with Custodiol in heart transplantation in children (CL-N-HTX-Paed-II/10/20)heart transplantation in childrenCTIS2023-510492-57-00Dr. Franz Koehler Chemie GmbH15
进行中（未招募）
1 期
A prospective randomized single blind multicenter phase II study of organ perfusion with Custodiol-N compared with Custodiol in heart transplantation in childrePreservation of hearts prior to heart transplantation in childrenMedDRA version: 21.1Level: PTClassification code 10019314Term: Heart transplantSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2022-001795-34-DEDr. Franz Köhler Chemie GmbH15
招募中
4 期
This is an investigator initiated study to compare the safety and performance of the TUXEDO and XIENCE Prime stent system in the treatment of Coronary lesion in Diabetic Mellitus patient population in India.CTRI/2011/06/001830Fortis Escorts Heart institute and Research centre1,830
尚未招募
不适用
Evaluating the treatment methods of proximal femur fractures in elderly trauma patientsACTRN12618001431213A/Prof Mark Rickman900