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LEVANT Japan Clinical Trial

Primary Purpose

Femoral Arterial Stenosis, Stenosis of Popliteal Arteries, Femoral Artery Occlusion

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MD02-LDCB Paclitaxel coated balloon catheter
Standard Uncoated Balloon Angioplasty Catheter
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Arterial Stenosis focused on measuring Arms, Experimental, Drug Coated Angioplasty Balloon, Active Comparator, Standard angioplasty balloon

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kansai Rosai Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LDCB

PTA

Arm Description

Paclitaxel Coated Balloon

Standard Uncoated Balloon Angioplasty Catheter PTA Catheter

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).

Full Information

First Posted
March 19, 2013
Last Updated
September 27, 2016
Sponsor
C. R. Bard
Collaborators
Medicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01816412
Brief Title
LEVANT Japan Clinical Trial
Official Title
A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
Collaborators
Medicon, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Arterial Stenosis, Stenosis of Popliteal Arteries, Femoral Artery Occlusion, Occlusion of Popliteal Arteries
Keywords
Arms, Experimental, Drug Coated Angioplasty Balloon, Active Comparator, Standard angioplasty balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LDCB
Arm Type
Experimental
Arm Description
Paclitaxel Coated Balloon
Arm Title
PTA
Arm Type
Active Comparator
Arm Description
Standard Uncoated Balloon Angioplasty Catheter PTA Catheter
Intervention Type
Device
Intervention Name(s)
MD02-LDCB Paclitaxel coated balloon catheter
Intervention Type
Procedure
Intervention Name(s)
Standard Uncoated Balloon Angioplasty Catheter
Other Intervention Name(s)
PTA Catheter
Primary Outcome Measure Information:
Title
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.
Description
Primary Patency
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
1, 3, 6, 12 and 24 months
Title
Efficacy
Description
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).
Time Frame
1, 3, 6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroyoshi Yokoi
Organizational Affiliation
Kokura Memorial Hospital Cardiovascular Internal Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osamu lida
Organizational Affiliation
Kansai Rosai Hospital Cardiovascular Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansai Rosai Hospital.
City
Amagasaki-shi
State/Province
Hyogo-ken.
ZIP/Postal Code
3-1-69
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31575518
Citation
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.
Results Reference
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LEVANT Japan Clinical Trial

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