Symptomatic occlusive disease of the peripheral arteries
Conditions
Interventions
Sponsors
Medicon Inc.
Eligibility
Sex/Gender
All
Inclusion 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
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 |
|---|---|
| Primary Patency at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary and Secondary Patency Target Lesion Revascularization (TLR) Rutherford classification Resting Ankle Brachial Index rate (ABI) Walking Impairment Questionnaire Quality of life score Death Amputation (above the ankle)-Free Survival (AFS) Target Vessel Revascularization (TVR) Major vascular complications | — |
Countries
Japan
Contacts
Public ContactSoji Iida
Medicon Inc. Clinical Development
Outcome results
None listed