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

Not Applicable

Completed

• Conditions: Peripheral Vascular Diseases
• Interventions: Device: POBA; Device: DEB

• Registration Number: NCT02750605
• Lead Sponsor: Skane University Hospital

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,

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-19
• Study Start: 2016-02
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Primary Completion: 2021-04-30
• Study Completion: 2022-08-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-29
• Last Update Posted: 2022-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain old balloon angioplasty	POBA	Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries
Drug eluting balloon angioplasty	DEB	Intervention with DEB angioplasty in long lesions of crural arteries

Primary Outcome Measures

Name	Time	Method
Clinical driven target lesion revascularization (TLR)	12 months	Porportion of patients that needs retreatment in in the monitored arterial segment
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.

Trial Locations

Locations (1)

Vascular center; 🇸🇪 Malmö, Sweden