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

NCT02750605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-12-30

No results posted yet for this study

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,

Conditions

  • Peripheral Vascular Diseases

Interventions

DEVICE

DEB

Intervention with drug eluting balloon.

DEVICE

POBA

Intervention with old technology as comparison

Sponsors & Collaborators

  • Skane University Hospital

    lead OTHER

Principal Investigators

  • Torbjörn Fransson · SUS, Malmö

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2021-04-30
Completion
2022-08-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02750605 on ClinicalTrials.gov