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

S

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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