A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW
NCT ID: NCT02962232
Last Updated: 2018-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
172 participants
INTERVENTIONAL
2016-11-30
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LEGFLOW OTW group
in the LEGFLOW OTW group the subject will be treated by the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW)
Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
treatment group
AMPHIRION DEEP group
in the AMPHIRION DEEP group the subject will be treated by PTA catheter (AMPHIRION DEEP)
PTA catheter
control group
Interventions
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Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
treatment group
PTA catheter
control group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* shall be treated earlier than the target lesion and
* shall be treated successfully. the successful treatment standard: 1) residual stenosis \<30%; 2) without flow limiting dissection 3) without thrombosis, embolism or any other serious adverse events
Exclusion Criteria
* 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;
* subjects requiring be intervention in bilateral lower limb;
* the stenosis lesion of ipsilateral femoral artery or ipsilateral popliteal artery have a diameter stenosis ≥50% untreated before the intervention operation;
* ipsilateral femoral artery or ipsilateral popliteal artery has single or adjacent lesion length ≥15cm, or ipsilateral femoral artery or ipsilateral popliteal artery has multiple lesion and one of these multiple lesion length ≥10cm or occlusion;
* \- adjacent lesion: 1) interval no more than 30 mm, 2) can be treated as a single lesion;
* \- multiple lesion: 1) interval no more than 30 mm, 2) need to be treated as multiple lesion;
* the residual stenosis still ≥30%, even when the length \<15cm and stenosis ≥50% single or adjacent lesion in ipsilateral femoral artery or ipsilateral popliteal artery has been treated, or when each lesion length \<10cm and stenosis ≥50% multiple lesion in ipsilateral femoral artery or ipsilateral popliteal artery has been treated;
* DES and /or DEB has been used in the inflow vessel of lesions treatment;
* subject has no patency vessel below the ankle artery before the intervention operation;
* target vessel aneurysm;
* acute or subacute thrombosis in target vessel;
* angiography shows severe calcification in the target lesion (before contrast injection or digital subtraction angiography, intensive annular calcifications that make target lesion not expansion and / or a calcification within the target lesion and locate on either sides of the vessel wall whose continuous length over than 5cm);
* lesions that the guild wire cannot pass through;
* subjects need be treated by thrombus endarterectomy, percutaneous transluminal plaque circumcision or laser treatment device indicate by intraoperative angiography;
18 Years
85 Years
ALL
No
Sponsors
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ZhuHai Cardionovum Medical Device Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chen zhong, professor
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Hainan General Hospital
Haikou, Hainan, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Beijing Anzhen Hospital Capital Medical University
Beijing, , China
Beijing Chao-Yang Hospital
Beijing, , China
Beijing Frendship Hospital, Capital Medical University
Beijing, , China
Beijing Hospital
Beijing, , China
Beijing Shijitan Hospital, Capital Medical University
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
Fuwai Hospital, Chinese Accadamy of Medical Sciences
Beijing, , China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Tianjing Medical University General Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Xiao Zhanxiang, professor
Role: primary
Role: backup
Jichun
Role: backup
Other Identifiers
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LEGFLOW-2015-02
Identifier Type: -
Identifier Source: org_study_id
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