Angioplasty, Balloon, Catheterization, Peripheral, Femoral Artery, Popliteal Artery
Conditions
Keywords
Drug-Coated Balloon, Superficial Femoral artery, popliteal peripheral Artery
Brief summary
This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.
Interventions
DEVICEIN.PACT drug coated balloon
Sponsors
Seung-Whan Lee, M.D., Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 19 and above * Subject with claudication or critical limb ischemia(Rutherford classification level 2\ 5) * Subject with total occlusion or stenosis ≥70%(de novo, restenosis) * Vessel diameter 4\ 6mm * Success to guide wire pass * Patients who don't have known hypersensitivity or allergy for dual-platelets * Willing and able to provide informed written consent
Exclusion criteria
* Acute stage * Acute thrombosis in target limb or target vessel * Failure to guide wire pass * Distal outflow * Lesion with poor inflow * Life expectancy ≤ 2 years * Allergic to paclitaxel * Pregnant or breast feeding woman or disagree with contraception or having children
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the event rate of composite event | 1 year | all cause death, revascularization due to amputation or clinical evidence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| target lesion revascularization | 2 years | — |
| The change of Rutherford classification | 2 years | — |
| The change of ABI(ankle-brachial index) score | 2 years | — |
| MACE | 2 years | major adverse cardiac event(death, myocardial infarction, stroke) |
| amputation of target limb | 2 years | — |
| cardiac death | 2 years | — |
| myocardial infarction | 2 years | — |
| stroke | 2 years | — |
| thrombosis | 2 years | — |
| all cause death | 2 years | — |
Countries
South Korea
Outcome results
None listed