To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery. This is a prospective, multicenter, prior desiged, randomize and controlled study, planned to enrol 172 subjects. all these subjects will be allocated 1:1 to the LEGFLOW OTW group n=86 and Admiral Xtreme group n=86. and accept the treatment of LEGFLOW and Admiral Xtreme balloon. and followed up at day 0-30, month 6, 12 by DUS and clinical examination. all the endpoint data will be assessed by DUS core-lab, CEC, then be statisticed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter
in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGHainan General Hospital
Haikou, Hainan, China
clinically driven target lesion revascularization (CD-TLR)
Time frame: 12 month post procedure
Procedural Success
Procedural Success defines as the blood supply of the target lesion regained after treatment, residual stenosis less than 50% and without flow-limiting dissection (≥type D) occurred.
Time frame: at 0-30 days
Device Success
Device Success defines as the device successfully delivered to the target location, inflated, deflated and withdrawn from the treated balloon inflation tube.
Time frame: at 0-30 days
Clinical Success
Clinical Success defines as operation success, and without any postoperative complication before discharge (death, lesions limb amputation, target lesion thrombosis or TVR)
Time frame: at 0-30 days
Change in Rutherford classification measured
Time frame: at 0-30 days, 6 months and 12 months post procedure
Change in ABI measure
Time frame: at 0-30 days, 6 months and 12 months post procedure
Walking capacity assessment by Walking Impairment Questionnaire (WIQ)
Time frame: at 0-30 days, 6 months and 12 months post procedure
Walking distance assessment by Six Minute Walk Test (6MWT)
Time frame: 0-30 days, 6 months and 12 months post procedure compared with baseline
Quality of life assessment by EQ5D
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The First hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGXiangya Hospital Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
RECRUITINGBeijing Anzhen Hospital, Capital Medical University
Beijing, China
NOT_YET_RECRUITINGBeijing Chao-yang Hospital, Capital Medical University
Beijing, China
RECRUITINGBeijing Hospital
Beijing, China
RECRUITINGBeijing Shijitan Hospital, Capital Medical University
Beijing, China
RECRUITINGFuwai Hospital, Chinese Accadamy of Medical Sciences
Beijing, China
RECRUITING...and 3 more locations
Time frame: at 0-30 days, 6 months and 12 months post procedure compared with baseline
Target lesion revascularization (TLR)
Time frame: 0-30 days, 6 months and 12 months post procedure
Target vessel revascularization (TVR)
Time frame: at 0-30 days, 6 months and 12 months post procedure
Thrombus at the target lesion site
Time frame: 0-30 days, 6 months and 12 months post procedure
Target limb amputation rates
Time frame: at 0-30 days, 6 months and 12 months post procedure
Major Adverse Event (MAE) rate which including all cause death, CD-TLR and major target limb amputation.
Time frame: at 0-30 days, 6 months and 12 months post procedure
Clinical-driven target vessel revascularization (CD-TVR) rates
Time frame: at 0-30 days, 6 months and 12 months post procedure
Clinical-driven target lesion revascularization (CD-TLR) rates
Time frame: at 0-30 days, 6 months and 12 months post procedure