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

Skane University Hospital

Status: Completed

Conditions: Peripheral Vascular Diseases

Treatments: Device: DEB; Device: POBA

Study type: Interventional

Funder types: Other

Identifiers

NCT02750605

TF3

Details and patient eligibility

About

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,

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Drug eluting balloon angioplasty

Experimental group

Description:

Intervention with DEB angioplasty in long lesions of crural arteries

Treatment:

Device: DEB

Plain old balloon angioplasty

Active Comparator group

Description:

Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries

Treatment:

Device: POBA