Peripheral Vascular Diseases
Conditions
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,
Interventions
Sponsors
Skane University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency of treated crural vessels | 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. |
| Clinical driven target lesion revascularization (TLR) | 12 months | Porportion of patients that needs retreatment in in the monitored arterial segment |
Countries
Sweden
Outcome results
None listed