Clinical trial NCT01816412: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Medicon, Inc.
First posted: 2013-03-22
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Safety
timeFrame: 1, 3, 6, 12 and 24 months
measure: Efficacy
timeFrame: 1, 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Amagasaki-shi
country: Japan
facility: Kansai Rosai Hospital.
state: Hyogo-ken.
Study officials:
affiliation: Kokura Memorial Hospital Cardiovascular Internal Medicine
name: Hiroyoshi Yokoi
role: PRINCIPAL_INVESTIGATOR
affiliation: Kansai Rosai Hospital Cardiovascular Internal Medicine
name: Osamu lida
role: PRINCIPAL_INVESTIGATOR
References:
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.