LEVANT Japan Clinical Trial

A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hyogo-ken.
    • Amagasaki-shi, Hyogo-ken., Japan, 3-1-69
      • Kansai Rosai Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LDCB; Paclitaxel Coated Balloon	Device: MD02-LDCB Paclitaxel coated balloon catheter
Active Comparator: PTA; Standard Uncoated Balloon Angioplasty Catheter PTA Catheter	Procedure: Standard Uncoated Balloon Angioplasty Catheter; Other Names: PTA Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Primary Patency	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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.	1, 3, 6, 12 and 24 months
Efficacy	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).	1, 3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Collaborators: Medicon, Inc.
• Investigators: Principal Investigator: Hiroyoshi Yokoi, Kokura Memorial Hospital Cardiovascular Internal Medicine; Principal Investigator: Osamu lida, Kansai Rosai Hospital Cardiovascular Internal Medicine

Publications and helpful links

General Publications

• Ouriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 22, 2013

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 27, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Experimental; Active Comparator; Arms; Drug Coated Angioplasty Balloon; Standard angioplasty balloon
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: MD02-LDCB