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

NCT02750605 | Completed

• 1 other identifier: TF3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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,

Conditions

Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Drug eluting balloon angioplasty

EXPERIMENTAL

Intervention with DEB angioplasty in long lesions of crural arteries

Device: DEB

Plain old balloon angioplasty

ACTIVE COMPARATOR

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

Device: POBA

Interventions

DEB DEVICE

Intervention with drug eluting balloon.

Drug eluting balloon angioplasty

POBA DEVICE

Intervention with old technology as comparison

Plain old balloon angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critical limb ischemia. Rutherford class 4-6
• Crural disease, long lesions, more than 2 cm.
• Life expectancy \> 1year
• \> 18 years

You may not qualify if:

• Pregnancy
• Patients disapproval
• Allergy to drug or contrast

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

Vascular center

Malmo, 23594, Sweden

Location

Related Publications (1)

• Fransson T, Mohammed Y, Gottsater A, Resch T. Prospective Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus Conventional Balloon Angioplasty in Treating Below the Knee Arterial Lesions in Chronic Limb Threatening Ischemia: The CRURAL DEB Study. J Endovasc Ther. 2025 Nov 20:15266028251388746. doi: 10.1177/15266028251388746. Online ahead of print.

  PMID: 41263159 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Torbjörn Fransson

  SUS, Malmö

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Vascular Surgery

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: April 25, 2016
• Study Start: February 1, 2016
• Primary Completion: April 30, 2021
• Study Completion: August 30, 2022
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)