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Physician-Initiated Trial Investigating the Efficacy of Endovascular Treatment of Femoropopliteal Arterial Stenotic Disease With the Biotronik Passeo-18 Lux Drug Releasing Balloon and the Biotronik Pulsar-18 Stent (Comparing With 4EVER Trial Results)

NCT02211664 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-13

No results posted yet for this study

Summary

The objective of this clinical investigation is to evaluate the short- and long-term (up to 24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing balloon and by Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions.

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

Passeo-18 balloon

DEVICE

Passeo-18 Lux drug releasing balloon

DEVICE

Pulsar-18 stent

Sponsors & Collaborators

  • Flanders Medical Research Program

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-02-28
Completion
2018-03-31

Countries

  • Belgium

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 NCT02211664 on ClinicalTrials.gov