Femoral Arterial Stenosis, Stenosis of Popliteal Arteries, Femoral Artery Occlusion, Occlusion of Popliteal Arteries
Conditions
Keywords
Arms, Experimental, Drug Coated Angioplasty Balloon, Active Comparator, Standard angioplasty balloon
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.
Interventions
DEVICEMD02-LDCB Paclitaxel coated balloon catheter
Sponsors
Medicon, Inc.
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | 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. | 6 months | Primary Patency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 1, 3, 6, 12 and 24 months | 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 | 1, 3, 6, 12 and 24 months | 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). |
Countries
Japan
Outcome results
None listed