Evaluation the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter （LEGFLOW）in Treatment of Stenosis or Occlusion in Below The Knee Arteries: A Prospective, Multicenter, Randomized, Controlled Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
- Enrollment
- 172
- Locations
- 19
- Primary Endpoint
- Target lesion restenosis determined by CTA
- Last Updated
- 7 years ago
Overview
Brief Summary
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion in below the knee artery.
Detailed Description
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion inbelow the knee artery. This is a prospective, multi-center, randomized, control, opening, superiority designed clinical study. Plan to enroll 172 eligible subjects in 15 centers in China, all these subjects will be randomized 1:1 to the study group (LEGFLOW OTW group, n=86) and control group (AMPHIRION DEEP group, n=86), and accept the treatment of LEGFLOW OTW and AMPHIRION DEEP respectively.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age from 18 to 85 years (include 18 and 85 year);
- •critical limb ischemia subjects (Rutherford classification from 3 to 6)
- •expective survival more than 1 year;
- •can understand the study objective, self willing enrolls and sign the informed consent, and accept scheduled followed up at the specific time.
- •Angiographic inclusive criteria:
- •reference vessel diameter 2.0-3.5mm;
- •stenosis or occlusion in arterial vasculature below the knee shall have distal outflow;
- •target lesion stenosis ≥70% or occlusion, length ≤270mm;
- •if subject has ipsilateral / contralateral iliac lesions, the iliac lesion shall meet all the following criteria:
- •iliac lesion or occlusion length ≤100mm and
Exclusion Criteria
- •subjects currently participate in other drugs or medical devices clinical study and have not reach the primary endpoint;
- •childbearing aged women whose pregnancy test before intervention operation is not negative, and lactating mothers;
- •subjects with renal function insufficiency (serum creatinine\> 2.5mg / dL or in renal dialysis);
- •subjects have known be allergy or contraindication to the contrast agent, paclitaxel, heparin, antiplatelet, anticoagulant or thrombolytic agents;
- •subjects plan to a major amputation (over metatarsal level);
- •stroke subjects within 3 months or stroke subjects with severe hemiplegia and aphasia associated sequelaes over 3 months before the intervention operation;
- •subjects with acute myocardial infarction, thrombolytic therapy or angina within 30 days before the intervention operation;
- •subjects whose target lesion limb have gangrene (the gangrene range over the metatarsophalangeal joint);
- •target lesion is a stenosis or occlusion that have prior been treated by scaffold implantation, DEB, ordinary balloon catheter or bypass graft;
- •lesions and /or occlusion locate or extend to popliteal artery or below ankle joint;
Outcomes
Primary Outcomes
Target lesion restenosis determined by CTA
Time Frame: 6 month post procedure
Restenosis defined as within the ± 5mm range beyond proximal and / or distal of target lesion, the lumen loss is greater than 50% of the reference vessel lumen diameter (RVD) follow-up by CTA. Target lesion revascularization (TLR): clinical symptoms of peripheral arterial disease recurrence or worsening, and any target lesion re-intervention caused by diameter stenosis ≥50% (confirmed by Doppler ultrasound, DSA or CT angiography).
Secondary Outcomes
- clinical success rate(at 0-30 days)
- device success rate(at 0-30 days)
- operation success rate(at 0-30 days)
- change of the Rutherford score(in day 0-30, 6th month, 12th month post operation)
- change of the life equality by EQ5D(in day 0-30, 6th month, 12th month post operation compares to baseline)
- target limb ulcer healing rate(in day 0-30, 6th month, 12th month post operation)
- target lesion revascularization rate(in day 0-30, 6th month, 12th month post operation)
- target limb upper amputation and lower amputation rate(in day 0-30, 6th month, 12th month post operation)
- major adverse event rate including all cause death, target limb upper amputation and target lesion revascularization(in day 0-30, 6th month, 12th month post operation)