Status:
COMPLETED
LEVANT Japan Clinical Trial
Lead Sponsor:
C. R. Bard
Collaborating Sponsors:
Medicon, Inc.
Conditions:
Femoral Arterial Stenosis
Stenosis of Popliteal Arteries
Eligibility:
All Genders
20-100 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01816412
Start Date
March 1 2013
End Date
June 1 2016
Last Update
September 28 2016
Active Locations (1)
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1
Kansai Rosai Hospital.
Amagasaki-shi, Hyōgo, Japan, 3-1-69