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OpenTrials
Completed

NCT Number: NCT02750605

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

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,

Completed

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular center

Malmö, 23594, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEB

Device

Intervention with drug eluting balloon.

POBA

Device

Intervention with old technology as comparison

Primary outcomes

  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.

  2. Clinical driven target lesion revascularization (TLR)

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Apr 25, 2016
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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