Status:
COMPLETED
Arterial Dissections After Angioplasty by Long vs Short Time of Balloon Inflation: the Randomized Controlled Trial.
Lead Sponsor:
Dumitru Casian
Conditions:
Peripheral Arterial Disease
Dissection Arterial
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background. Arterial dissections represent the typical complication of the percutaneous transluminal angioplasty for femoropopliteal disease and have negative impact upon the outcomes of the treatment...
Detailed Description
Background. Arterial dissections represent the typical complication of the percutaneous transluminal angioplasty for femoropopliteal disease, with an incidence of 20-60% depending of the severity of t...
Eligibility Criteria
Inclusion
- Chronic limb threatening ischemia category 4-6 according to Rutherford classification;
- Ankle-brachial index \<0.8 or \>1.4
- Clinical stage ≥2 of WIfI (Wound, Ischemia, foot Infection) classification;
- Stenosis of ≥50% or occlusion in superficial femoral or popliteal artery, confirmed by duplex ultrasound, computer tomography angiography or digital subtraction angiography;
- Use of endovascular approach for treatment of the lesion;
- Patient willing to sign informed consent.
Exclusion
- Acute arterial occlusion (symptoms duration less than 14 days);
- Recurrent stenosis or occlusion of femoropopliteal segment;
- Impossibility to cross the lesion intraluminally during the endovascular intervention;
- Life expectancy of less than 1 year -
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04442802
Start Date
August 24 2020
End Date
June 23 2023
Last Update
November 28 2023
Active Locations (1)
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1
Nicolae Testemitanu State University of Medicine and Pharmacy, Department of surgery nr.3, Vascular Surgery Clinic
Chisinau, Moldova, 2001