Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.
Phase 4
Completed
- Conditions
- Atherosclerosis of Artery
- Interventions
- Procedure: Angioplasty of distal arteries
- Registration Number
- NCT02715830
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in which 40 procedures to treat one artery (standart) or more than one artery in the same procedure.
The aim of this study is to know if this strategy increase healing velocity and limb salvage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Occlusion of the three arteries bellow the knee previously
- Rutherford 5 - ischemic lesion of the foot
- Informative Term
- At least one patente vessel in pedal arch
Exclusion Criteria
- allergy to aspirin, clopidogrel or contrast media
- renal impairment
- Tasc D lesion in femoral or popliteal arteries
- no undersatnting patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description More than one artery Angioplasty of distal arteries In this arm, after obtain a good result of the angioplasty of one artery, we continue trying one or two more arteries One Artery Angioplasty of distal arteries In this arm after obtain the good result after the angioplasty of one artery the procedure stops
- Primary Outcome Measures
Name Time Method Time of wound healing 1 year Time in days necessary to the complete healing of the wound
Limb Salvage 1 year Time free of major amputation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Santa Marcelina Hospital
🇧🇷Sao Paulo, Brazil