Infrainguinal symptomatic peripheral artery disease with chronic total occlusion
Conditions
Interventions
None listed
Sponsors
Kokura Memorial Hospital, Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Informed consent was done 2)Infrainguinal peripheral artery disease with chronic total occulusion(included in-stent occulusion) 3)Atherosclerotic peripheral artery disease (Rutherford category 2-5) 4)ABI value was less than 0.9 or if the value was more than 0.9, the ischemia of lower limb was confirmed by other modalities. 5)Meet the criteria of EVT 6)More than 20 years old 7)Agreement the clinical follow up.(after procedure, 6 months, 12 months)
Exclusion criteria
Exclusion criteria: 1)Less than 20 years old 2)Pregnancy 3)Stenotc lesions 4)Common femoral artery lesion (If EVT are going to perform for Iliac lesions simultaneously, it allows the study). 5)Planed other clinical study 6)Planed surgical bypass, below/above the knee amputation within 30 days 7)Poor life expectancy 8)Difficulty of antiplatelet therapy, anticoagrant therapy 9)Severe dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure success (TruePath CTO device cross the target occlusion through to the true distal lumen) | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication Proportion of true lumen using IVUS analysis Procedure time, device using time, fluoroscopy time, dose Improvement of Rutherford category | — |
Countries
Japan
Contacts
Public ContactYusuke Tomoi
Kokura Memorial Hospital Cardiology
Outcome results
None listed