Evaluation of the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter （LEGFLOW）in Treatment of Stenosis or Occlusion in Femoral-popliteal Arteries：A Prospective, Multicenter, Randomized, Controlled Clinical Study

ZhuHai Cardionovum Medical Device Co., Ltd.13 sites in 1 country172 target enrollmentDecember 2016

ConditionsPeripheral Arterial Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
Enrollment: 172
Locations: 13
Primary Endpoint: clinically driven target lesion revascularization (CD-TLR)
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

June 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ZhuHai Cardionovum Medical Device Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years and ≤ 85 years.
•De novo or restenotic lesions in the femoral popliteal artery due to atherosclerosis, which located in the superficial femoral artery and/or proximal popliteal artery (arterial segment starting at least 1cm beyond the common femoral artery bifurcation to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella). And the patients are suitable for endovascular therapy with LEGFLOW OTW or Admiral Xtreme.
•Rutherford class 2 to
•Target lesion length ≤ 200mm.
•Target lesion stenosis ≥ 70% or total occlusion, and it can be passed with common manipulation.
•Reference vessel diameter ≥ 4mm and ≤ 8mm by visual estimate.
•Target lesion consists of a single of de novo or restenotic lesion, or a adjacent lesion or a combination lesion or multiple lesion which meets the following criteria:
•adjacent lesion: (1) lesion space ≤ 30mm; (2) total lesion length (include lesion space) ≤ 200mm; (3) can be treated as a single lesion.
•Combination lesion: combination lesion is defined as not a chronic total occlusion (CTO), but may include a part of total occlusion (100% stenosis). The total lesion length ≤ 200mm.
•Multiple lesion: (1) lesion space \> 30mm; (2) total lesion length (include lesion space) ≤ 200mm; (3) can be treated as multiple lesions.

Exclusion Criteria

•Women of childbearing age with negative pregnancy test before procedure, and breastfeeding women.
•Stroke or STEMI within 30 days prior to the procedure.
•Either local or systemic thrombolytic therapy within 6 weeks prior to the procedure.
•Any major surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
•Any major selective surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
•Restenotic lesions after DCB or bypass surgery.
•Target limb has been previously treated with bypass surgery.
•Guidewire must be passed through from the distal part of limb.
•Known allergies or sensitivities to contrast agent, paclitaxel, anti-platelet, anticoagulants or thrombolytic drugs.
•Known allergies or sensitivities to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II.

Outcomes

Primary Outcomes

clinically driven target lesion revascularization (CD-TLR)

Time Frame: 12 month post procedure

Secondary Outcomes

Procedural Success(at 0-30 days)
Device Success(at 0-30 days)
Change in Rutherford classification measured(at 0-30 days, 6 months and 12 months post procedure)
Change in ABI measure(at 0-30 days, 6 months and 12 months post procedure)
Walking capacity assessment by Walking Impairment Questionnaire (WIQ)(at 0-30 days, 6 months and 12 months post procedure)
Target limb amputation rates(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.(at 0-30 days, 6 months and 12 months post procedure)
Clinical-driven target vessel revascularization (CD-TVR) rates(at 0-30 days, 6 months and 12 months post procedure)
Walking distance assessment by Six Minute Walk Test (6MWT)(0-30 days, 6 months and 12 months post procedure compared with baseline)
Clinical Success(at 0-30 days)
Target vessel revascularization (TVR)(at 0-30 days, 6 months and 12 months post procedure)
Clinical-driven target lesion revascularization (CD-TLR) rates(at 0-30 days, 6 months and 12 months post procedure)
Quality of life assessment by EQ5D(at 0-30 days, 6 months and 12 months post procedure compared with baseline)
Target lesion revascularization (TLR)(0-30 days, 6 months and 12 months post procedure)
Thrombus at the target lesion site(0-30 days, 6 months and 12 months post procedure)