Symptomatic occlusive disease of the peripheral arteries
Conditions
Interventions
Sponsors
Medicon Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-breastfeeding female >=20 but <80 years of age; 2. Rutherford Clinical Category 4-5; 3. Life expectancy >=1 year; 4. Patient has been receiving chronic hemodialysis treatments (>=3 times per week) for End Stage Renal Disease (ESRD) for >=3 months (NOTE: Peritoneal dialysis treatments are not allowed); 5. Significant stenosis (>=70%) or occlusion of native artery(s) above the tibiotalar joint; etc.
Exclusion criteria
Exclusion criteria: 1. History of stroke within 3 months; 2. History of MI, thrombolysis or angina within 30 days of enrollment; 3. Prior or planned major amputation (of either leg); etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Freedom from BTK MALE+POD at 30-Days - Composite of limb salvage and primary patency at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary patency, Hemodynamic outcome, Clinically-driven TLR, and wound healing | — |
Countries
Japan
Contacts
Public ContactSoji Iida
Medicon Inc. Clinical Development
Outcome results
None listed