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Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions

NCT01763476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-08-03

No results posted yet for this study

Summary

There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%.

The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.

Conditions

Interventions

PROCEDURE

paclitaxel-coated balloon angioplasty

plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion

PROCEDURE

atherectomy

atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion

Sponsors & Collaborators

  • Medical University of Graz

    collaborator OTHER

  • Herz-Zentrums Bad Krozingen

    lead OTHER

Principal Investigators

  • Franz-Josef Neumann, M.D. · Universitaets-Herzzentrum Freiburg-Bad Krozingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT01763476 on ClinicalTrials.gov