Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

August 5, 2023 updated by: Torbjorn Fransson, Skane University Hospital

Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries"

Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Critical limb ischemia RC 4-6

Lesions in superficial femoral artery and popliteal artery (p1 -p2)

Target vessel 4-8mm

At least I 1 vessel runoff to the foot

Age >18 years

Exclusion Criteria:

Pregnancy

Patient disapproval

Age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug Eluting Stent (DES)
Drug Eluting Stent (DES). Zilver PTX.
Device: Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Placebo Comparator: Bare Metal Stent (BMS)
Bare Metal Stent (BMS). Zilver Flex
Device: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from TLR (Target Lesion Revascularization)
Time Frame: 6 months
Fraction of study subjects without need for retreatment at treatment location
6 months
Freedom from TLR (Target Lesion Revascularization)
Time Frame: 12 months
Fraction of study subjects without need for retreatment at treatment location
12 months
Freedom from TLR (Target Lesion Revascularization)
Time Frame: 24 months
Fraction of study subjects without need for retreatment at treatment location
24 months
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
Time Frame: 12months
Functioning revascularization without adjunctive measures
12months
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
Time Frame: 24 months
Functioning revascularization without adjunctive measures
24 months
Event Free Survival
Time Frame: 24 months
Alive without vascular events
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skane University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 5, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TF2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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