NL-OMON55654已完成不适用
ProspectIve, MuLti-Center Study to EvaLUate TreatMent of subjects with OcclusivE Disease with a Novel PAcliTaxel-CoatEd Angioplasty Balloon in Below-The- Knee (BTK) arteries: a Post Market clinical Study - ILLUMENATE BTK Post Market Study
Philips Image Guided Therapy Corporation0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- •1. Subjects intended to be treated with the Stellarex 0.014* Drug-Coated
- •Balloon for de-novo or restenotic lesions in native *below the knee* popliteal
- •(P3 segment) and infra-popliteal arteries ending at the tibiotalar joint
- •(ankle), as per the Instruction for Use (IFU).
- •2. Rutherford-Becker clinical category classification (RCC) 3 patients with
- •claudication or RCC 4 or 5 subjects with documented Critical Limb Ischemia
- •(CLI) defined as
- •2.1 RCC 3 subjects: subjects with severe claudication
- •2.2 RCC 4 subjects: subjects with persistent, recurring ischemic rest pain
- •requiring analgesia for at least two weeks; or
- •2.3 RCC 5 subjects: subjects with minor tissue loss of the foot or toes; or
- •3. Age >=18 years old.
- •4. Reconstitution of the target vessel at the ankle and run-off into a patent
- •dorsalis pedis or plantar arteries defined as <50% stenosis by visual estimate.
- •5. Is able and willing to provide written informed consent and comply with all
- •required follow-up evaluations within the defined follow- up visit windows
- •prior to enrollment in the study.
- •6. Life expectancy > 1 year.
排除标准
- •1. Subjects with any medical condition that would make him/her inappropriate
- •for treatment with the Stellarex balloon as per the Instructions for Use (IFU)
- •or in the opinion of the investigator.
- •2. Has impaired renal function defined as serum creatinine >2.5 mg/dl that
- •cannot be adequately pre-treated or subjects on dialysis.
- •3. Subjects already enrolled in other investigational (interventional) studies
- •that would interfere with study endpoints.
- •4. Subjects that in the judgment of the investigator would require treatment of
- •the contralateral limb within 3 days prior to the index procedure or 30 days
- •after. Note: Unless contralateral treatment is required to facilitate adequate
- •access to the target lesion (e.g. contralateral iliac).
- •5. Previous or planned surgical or catheter-based procedure within 3 days
- •before or 30 days after the index procedure. Note: This excludes successful
- •inflow artery treatment within the same hospitalization or a documented
- •preplanned minor amputation. Successful inflow artery treatment is defined as
- •attainment of residual diameter stenosis <= 30% without major vascular
- •complication (e.g. absence of flow-limiting dissection, embolic event). These
- •inflow arteries must be treated without the need for laser, atherectomy,
- •thrombectomy, cryoplasty, brachytherapy and cutting/scoring balloons. Treatment
- •with a Stellarex DCB of the inflow lesion, if according to its intended use, is
- •6. Prior endovascular treatment of the target lesion within three (3) months of
- •the index procedure.
- •7. Prior stent placement in the target lesion(s).
- •8. Single focal lesion < 4cm in length in the absence of additional
- •treatable popliteal or infra-popliteal lesions.
- •9. Subjects confined to bed that are completely non-ambulatory.
- •10. For RCC 5 subjects: Non-arterial ulcers such as venous ulcers, neurotrophic
- •ulcers, heel pressure ulcers, ulcers potentially involving calcaneus region or
- •ulcers in the proximal one-half of the foot or higher (from mid-foot and higher
- •going up the leg).
- •11. Subjects scheduled to undergo a planned major amputation.
- •12. Presence of concentric calcification that precludes adequate
- •vessel preparation per IFU.
研究者
相似试验
已完成
4 期
Clinical study for HemoRel-A® in Hemophilia A patientsCTRI/2018/05/013790Dr Savita Rangarajan44
已完成
4 期
To study the safety and efficacy of Ranibizumab of Intas Pharmaceuticals Ltd. in patients with visual impairment.CTRI/2016/03/006739Intas Pharmaceuticals Ltd126
已完成
不适用
A prospective, multicenter clinical trial to evaluate the safety and the effectiveness of the AEGEA Vapor System* for the treatment of excessive uterine bleeding.Excessive uterus bleedingheavy menses10013326NL-OMON41262AEGEA Medical Inc.18
尚未招募
不适用
Prospective, clinical, multicentric study to evaluate the influence of the length of the membranous urethra on stress urinary incontinence after robot-assisted radical prostatectomyC61Malignant neoplasm of prostateDRKS00024607Krankenhaus der Barmherzigen Brüder Wien500
招募中
不适用
A prospective multicenter study of patients treated with molecular target therapy for hepatocellular carcinomaHepatocellular carcinomaJPRN-UMIN000010085Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology300