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Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis

NCT02540018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2023-03-13

No results posted yet for this study

Summary

The aim of this clinical trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel drug-eluting balloon (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term patency.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries

Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure (DEB) is assigned by randomization. Luminor35®-DEB PTA catheter is applied.

DEVICE

Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter

Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure is assigned by randomization. POBA catheter is applied.

Sponsors & Collaborators

  • iVascular S.L.U.

    collaborator INDUSTRY

  • KKS Netzwerk

    collaborator NETWORK

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • René Aschenbach, PD Dr. med. · University Hospital Jena, Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2016-12-31
Completion
2022-01-14

Countries

  • Germany

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 NCT02540018 on ClinicalTrials.gov