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

Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries

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 Overview

• Status: Completed
• Conditions: Peripheral Vascular Diseases
• Intervention / Treatment: Device: DEB; Device: POBA

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 23594
    • Vascular center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug eluting balloon angioplasty; Intervention with DEB angioplasty in long lesions of crural arteries	Device: DEB; Intervention with drug eluting balloon.
Active Comparator: Plain old balloon angioplasty; Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries	Device: POBA; Intervention with old technology as comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Clinical driven target lesion revascularization (TLR)	Porportion of patients that needs retreatment in in the monitored arterial segment	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical driven target lesion revascularization (TLR)	Porportion of patients that needs retreatment in in the monitored arterial segment	12 months

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Investigators: Principal Investigator: Torbjörn Fransson, SUS, Malmö

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: TF3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No