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

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ClinicalTrials.gov Identifier: NCT02750605
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Torbjorn Fransson, Skane University Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : February 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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




Primary Outcome Measures :
  1. Primary patency of treated crural vessels [ Time Frame: 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) [ Time Frame: 12 months ]
    Porportion of patients that needs retreatment in in the monitored arterial segment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750605


Contacts
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Contact: Torbjörn Fransson +4640338691 torbjorn.fransson@skane.se

Locations
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Sweden
Vascular center Recruiting
Malmö, Sweden, 23594
Contact: Torbjörn Fransson    +4640338691    torbjorn.fransson@skane.se   
Sponsors and Collaborators
Skane University Hospital
Investigators
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Principal Investigator: Torbjörn Fransson SUS, Malmö

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Responsible Party: Torbjorn Fransson, Consultant, Vascular Surgery, Skane University Hospital
ClinicalTrials.gov Identifier: NCT02750605     History of Changes
Other Study ID Numbers: TF3
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases