Clinical trial NCT02962232: A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: drug eluting balloon
arterial vasculature below the knee
Lead sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
  * 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:

* 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;
* 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;

Primary outcomes:
measure: Target lesion restenosis determined by CTA
timeFrame: 6 month post procedure
Secondary outcomes:
measure: device success rate
timeFrame: at 0-30 days
measure: operation success rate
timeFrame: at 0-30 days
measure: clinical success rate
timeFrame: at 0-30 days
measure: change of the Rutherford score
timeFrame: in day 0-30, 6th month, 12th month post operation
measure: change of the life equality by EQ5D
timeFrame: in day 0-30, 6th month, 12th month post operation compares to baseline
measure: target limb ulcer healing rate
timeFrame: in day 0-30, 6th month, 12th month post operation
measure: target lesion revascularization rate
timeFrame: in day 0-30, 6th month, 12th month post operation
measure: target limb upper amputation and lower amputation rate
timeFrame: in day 0-30, 6th month, 12th month post operation
measure: major adverse event rate including all cause death, target limb upper amputation and target lesion revascularization
timeFrame: in day 0-30, 6th month, 12th month post operation
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Beijing Anzhen Hospital Capital Medical University
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Beijing Frendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Accadamy of Medical Sciences
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine
city: Tianjin
country: China
facility: Tianjing Medical University General Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: Chen zhong, professor
role: PRINCIPAL_INVESTIGATOR
References: