NCT01094678

Brief Summary

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
788

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 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

Study Start

First participant enrolled

April 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

2.8 years

First QC Date

March 25, 2010

Last Update Submit

September 9, 2014

Conditions

Peripheral Arterial DiseasePeripheral Vascular Disease

Keywords

Peripheral Aterial Disease (PAD)Peripheral Vascular DiseaseDrug-Eluting StentDrug-Coated StentVascular DiseasesCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Event-free Survival

    6 months

Study Arms (1)

Stent

EXPERIMENTAL
Device: Zilver® PTX™ Stent

Interventions

Zilver® PTX™ StentDEVICE

Stenting of the superfemoropopliteal artery.

Stent

Eligibility Criteria

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

You may qualify if:

  • stenosis of the above-the-knee femoropopliteal artery
  • appropriate size and location of the lesion

You may not qualify if:

  • pregnant or breast feeding
  • failure or inability to give informed consent
  • simultaneously participating in another drug or device study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Heart Center Leipzig, Angiology

Leipzig, 04289, Germany

Location

St. Franziskus Hospital Munster

Münster, 48145, Germany

Location

Universitat Klinik Tubingen

Tübingen, 72072, Germany

Location

University of Roma La Sapienza

Rome, 00161, Italy

Location

Related Publications (4)

  • Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.

    PMID: 33025243DERIVED

  • Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T; Zilver PTX Investigators. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013 Jun 18;61(24):2417-2427. doi: 10.1016/j.jacc.2013.03.034. Epub 2013 Apr 10.

    PMID: 23583245DERIVED

  • Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U, Kultgen PL, Rastan A. Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents. JACC Cardiovasc Interv. 2013 Mar;6(3):274-81. doi: 10.1016/j.jcin.2012.12.118.

    PMID: 23517839DERIVED

  • Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, Ruhlmann C, Kavteladze Z, Lottes AE, Ragheb AO, Zeller T; Zilver PTX Single-Arm Study Investigators. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011 Oct;18(5):613-23. doi: 10.1583/11-3560.1.

    PMID: 21992630DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Michael Dake, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 29, 2010

Study Start

April 1, 2006

Primary Completion

January 1, 2009

Study Completion

April 1, 2011

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

IT(1)DE(3)