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

Peripheral Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750605
• Other study ID #: TF3
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: August 30, 2022

Study information

• Verified date: December 2022
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• DEB
Intervention with drug eluting balloon.
• POBA
Intervention with old technology as comparison

Locations

Country	Name	City	State
Sweden	Vascular center	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinical driven target lesion revascularization (TLR)	Porportion of patients that needs retreatment in in the monitored arterial segment	12 months