NCT02936622

Brief Summary

This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2019

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

October 12, 2016

Last Update Submit

April 4, 2024

Conditions

Peripheral Arterial Disease (PAD)

Outcome Measures

Primary Outcomes (1)

  • The percent diameter stenosis within the study lesion evaluated by conventional angiography.

    Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.

    6 months

Study Arms (3)

Stent 1

EXPERIMENTAL

Zilver® PTX Stent

Device: Zilver® Paclitaxel-Eluting Peripheral Stent

Stent 2

EXPERIMENTAL

Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Device: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Stent 3

EXPERIMENTAL

Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Device: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Interventions

Zilver® Paclitaxel-Eluting Peripheral StentDEVICE

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Stent 1
Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coatingDEVICE

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Stent 2
Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coatingDEVICE

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Stent 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
  • Symptoms of peripheral arterial disease (Rutherford 2-4)

You may not qualify if:

  • Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
  • Less than 18 years old
  • Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
  • Previous stent in the study vessel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Klinikum Hochsauerland

Arnsberg, 59759, Germany

Location

Universitäts Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Krankenhaud Bucholz

Buchholz, 21244, Germany

Location

St. Josefskrankenhaus Heidelberg

Heidelberg, 69115, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

SRH Klinikum Karlsbad- Langensteinbach GmbH

Karlsruhe, 76307, Germany

Location

Universitatsklinikum Leipzig AoR

Leipzig, 04103, Germany

Location

MEDINOS Kliniken des Landkreises Sonneberg GmbH

Sonneberg, 96515, Germany

Location

Marienhospital Stuttgart

Stuttgart, 70199, Germany

Location

Uniklinikum Würzburg

Würzburg, 70199, Germany

Location

Auckland City Hospital, New Zealand

Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Thomas Zeller, Prof. Dr. med.

    Universitäts Herzzentrum Freiburg - Bad Krozingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 18, 2016

Study Start

February 21, 2017

Primary Completion

April 23, 2019

Study Completion

October 25, 2023

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations

NZ(1)DE(10)