A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW
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|ClinicalTrials.gov Identifier: NCT02962232|
Recruitment Status : Unknown
Verified November 2018 by ZhuHai Cardionovum Medical Device Co., Ltd..
Recruitment status was: Recruiting
First Posted : November 11, 2016
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease||Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter Device: PTA catheter||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: LEGFLOW OTW group
in the LEGFLOW OTW group the subject will be treated by the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW)
Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
Other Name: LEGFLOW OTW
Active Comparator: AMPHIRION DEEP group
in the AMPHIRION DEEP group the subject will be treated by PTA catheter (AMPHIRION DEEP)
Device: PTA catheter
Other Name: AMPHIRION DEEP
- 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).
- device success rate [ Time Frame: at 0-30 days ]device success defines as: the device successfully delivered to the target location, inflated, deflated and withdrawn from the treated balloon inflation tube.
- operation success rate [ Time Frame: at 0-30 days ]operation 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.
- clinical success rate [ Time Frame: at 0-30 days ]clinical success defines as: operation success, and without any postoperative complication before discharge (death, lesions limb amputation, target lesion thrombosis or TVR)
- change of the Rutherford score [ Time Frame: in day 0-30, 6th month, 12th month post operation ]
- change of the life equality by EQ5D [ Time Frame: in day 0-30, 6th month, 12th month post operation compares to baseline ]
- target limb ulcer healing rate [ Time Frame: in day 0-30, 6th month, 12th month post operation ]healing or not, if not: improve, no change, or progression;
- target lesion revascularization rate [ Time Frame: in day 0-30, 6th month, 12th month post operation ]
- target limb upper amputation and lower amputation rate [ Time Frame: 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 [ Time Frame: in day 0-30, 6th month, 12th month post operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962232
|Contact: Chen zhong, firstname.lastname@example.org|
|Principal Investigator:||Chen zhong, professor||Beijing Anzhen Hospital|