Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Skane University Hospital
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Clinical driven target lesion revascularization (TLR)
Study Overview
Brief Summary
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study
Results will be defined as:
Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.
Primary endpoints:
Primary Patency at 12 months, TLR (clinical driven),
Secondary endpoints:
Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Critical limb ischemia. Rutherford class 4-6
- •Crural disease, long lesions, more than 2 cm.
- •Life expectancy > 1year
- •> 18 years
Exclusion Criteria
- •Pregnancy
- •Patients disapproval
- •Allergy to drug or contrast
Outcomes
Primary Outcomes
Clinical driven target lesion revascularization (TLR)
Time Frame: 12 months
Porportion of patients that needs retreatment in in the monitored arterial segment
Primary patency of treated crural vessels
Time Frame: 12 months
Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open.
Secondary Outcomes
No secondary outcomes reported
Investigators
Torbjorn Fransson
Consultant, Vascular Surgery
Skane University Hospital