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DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia | Clinical Trials | Clareo Health

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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

NCT02750605•Skane University Hospital

View on ClinicalTrials.gov

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,

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Vascular center

Malmo, Sweden

Key Dates

Start Date

February 1, 2016

Primary Completion Date

April 30, 2021

Completion Date

August 30, 2022

Last Updated

December 30, 2022

Enrollment

ACTUAL participants

Conditions

Peripheral Vascular Diseases

Interventions

DEB

DEVICE

POBA

DEVICE

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

NCT06656988

Peripheral Vascular DiseasesKidney Diseases

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RECRUITING

Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

NCT04927156

Intracranial AneurysmBrain Arterial Disease+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

Fisetin to Reduce Senescence and Mobility Impairment in PAD

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Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes

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