MedTrace Logo

Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis

NCT02033135 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-01-10

No results posted yet for this study

Summary

This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis.

Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.

Conditions

  • Peripheral Arterial Disease

Interventions

PROCEDURE

Angioplasty with Zilver PTX

Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)

OTHER

Best medical treatment

Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.

DEVICE

Zilver PTX

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Torben V Schroeder, MD, MDSc · Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-04-30
Completion
2017-08-31

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT02033135 on ClinicalTrials.gov