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
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 19, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 28, 2016
September 1, 2016
1.8 years
March 19, 2013
September 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Safety
1, 3, 6, 12 and 24 months
Efficacy
1, 3, 6, 12 and 24 months
Study Arms (2)
LDCB
EXPERIMENTALPaclitaxel Coated Balloon
PTA
ACTIVE COMPARATORStandard Uncoated Balloon Angioplasty Catheter PTA Catheter
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
- Medicon, Inc.collaborator
Study Sites (1)
Kansai Rosai Hospital.
Amagasaki-shi, Hyōgo, 3-1-69, Japan
Related Publications (1)
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.
PMID: 31575518DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroyoshi Yokoi
Kokura Memorial Hospital Cardiovascular Internal Medicine
- PRINCIPAL INVESTIGATOR
Osamu lida
Kansai Rosai Hospital Cardiovascular Internal Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2013
First Posted
March 22, 2013
Study Start
March 1, 2013
Primary Completion
December 1, 2014
Study Completion
June 1, 2016
Last Updated
September 28, 2016
Record last verified: 2016-09