DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia

Skane University Hospital70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Peripheral Vascular Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Primary patency of treated crural vessels

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.

Time frame: 12 months

Clinical driven target lesion revascularization (TLR)

Porportion of patients that needs retreatment in in the monitored arterial segment