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

• Sponsor: Skane University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02750605
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 76.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

Secondary endpoints:

Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events, TLR (clinical driven),

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Diseases	Device: DEB; Device: POBA	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Apr 30, 2021
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Secondary Outcome Measures

1. Clinical driven target lesion revascularization (TLR) [12 months]

   Porportion of patients that needs retreatment in in the monitored arterial segment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vascular center	Malmö		Sweden	23594

Sponsors and Collaborators

• Skane University Hospital

Investigators

• Principal Investigator: Torbjörn Fransson, SUS, Malmö

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Torbjorn Fransson, Consultant, Vascular Surgery, Skane University Hospital
• ClinicalTrials.gov Identifier: NCT02750605
• Other Study ID Numbers: TF3
• First Posted: Apr 25, 2016
• Last Update Posted: Mar 8, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ischemia

Study Results

No Results Posted as of Mar 8, 2022