LEVANT Japan Clinical Trial

Phase 2

Completed

• Conditions: Femoral Artery Occlusion; Stenosis of Popliteal Arteries; Occlusion of Popliteal Arteries; Femoral Arterial Stenosis
• Interventions: Procedure: Standard Uncoated Balloon Angioplasty Catheter; Device: MD02-LDCB Paclitaxel coated balloon catheter

• Registration Number: NCT01816412
• Lead Sponsor: C. R. Bard

Brief Summary

To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.

Detailed Description

The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-22
• Primary Completion: 2014-12
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Male or non-pregnant female ≥20 years of age;
• Rutherford Clinical Category 2-4;
• Length ≤15 cm;
• ≥70% stenosis
• Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
• A patent inflow artery as confirmed by angiography
• At least one patent native outflow artery to the ankle

Exclusion Criteria

• Life expectancy of < 2 years;
• History of hemorrhagic stroke within 3 months;
• Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
• History of MI, thrombolysis or angina within 2 weeks of enrollment;
• Renal failure or chronic kidney disease
• Severe calcification that renders the lesion un-dilatable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTA	Standard Uncoated Balloon Angioplasty Catheter	Standard Uncoated Balloon Angioplasty Catheter PTA Catheter
LDCB	MD02-LDCB Paclitaxel coated balloon catheter	Paclitaxel Coated Balloon

Primary Outcome Measures

Name	Time	Method
Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.	6 months	Primary Patency

Secondary Outcome Measures

Name	Time	Method
Safety	1, 3, 6, 12 and 24 months	Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.
Efficacy	1, 3, 6, 12 and 24 months	Primary Patency of the target lesion at 6 months. Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).

Trial Locations

Locations (1)

Kansai Rosai Hospital.; 🇯🇵 Amagasaki-shi, Hyogo-ken., Japan