Trial record 1 of 1 for:    NCT01901289
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Zilver® PTX® V Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01901289
First received: July 8, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.


Condition Intervention
Peripheral Arterial Disease
Device: Zilver® PTX® Drug-Eluting Peripheral Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Occurrence of target lesion revascularization (TLR). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Target lesion revascularization (TLR) [ Time Frame: annually through five years post-procedure. ] [ Designated as safety issue: Yes ]
  • Stent Integrity [ Time Frame: one, three, and five years post-procedure. ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: annually through five years post-procedure. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2013
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug-Eluting Stent Device: Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has signed and dated the informed consent.
  • Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
  • Patient agrees to return for the required follow-up assessments.

Exclusion Criteria:

  • Patient is < 18 years of age.
  • Patient has significant stenosis of inflow tract not successfully treated before this procedure.
  • Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901289

Contacts
Contact: Cassandra Wood 765-463-7537 cwood@medinst.com

Locations
United States, California
Stanford University Medical School Recruiting
Stanford, California, United States, 94305
Contact: Jason Lee, MD    650-724-8292    jtlee@stanford.edu   
United States, Connecticut
Yale New Haven School of Medicine Withdrawn
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Nelson Bernardo, MD    202-877-5975    nelson.l.bernardo@medstar.net   
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Robert Feezor, MD    352-273-7020    Robert.feezor@surgery.ufl.edu   
The Cardiac and Vascular Institute Recruiting
Gainesville, Florida, United States, 32605
Contact: Arthur Lee, MD    352-331-8570    leeivc@gmail.com   
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32216
Contact: Yazan Khatib, MD    904-493-3333    ykhatib@firstcoastcardio.com   
United States, Iowa
Genesis Health System Withdrawn
Davenport, Iowa, United States, 52803
United States, Maryland
Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Mahmoud Malas, MD    410-550-5332    bmalas1@jhmi.edu   
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Allen Hamdan, MD    617-632-9953    ahamdan@BIDMC.harvard.edu   
United States, New York
Montefiore Medical Center Withdrawn
Bronx, New York, United States, 10467
New York-Presbyterian/ Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Darren Schneider, MD    212-746-5192    dbs9003@med.cornell.edu   
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Nicholas J Morrissey, MD    212-342-2929    njm2106@columbia.edu   
United States, Ohio
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Gary Ansel, MD    614-262-6772    GANSEL2@OhioHealth.com   
University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Mark Burket, MD    419-383-4087    mark.burket@utoledo.edu   
United States, Pennsylvania
Holy Spirit Hospital Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Rajesh Dave, MD    717-724-6304    rdintervention@yahoo.com   
United States, South Carolina
South Carolina Heart Center Recruiting
Columbia, South Carolina, United States, 29204
Contact: Patrick Hall, MD    803-355-2927    paxhall@earthlink.com   
Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29615
Contact: Bruce Gray, DO    864-455-9833    bhgray@ghs.org   
United States, Tennessee
Holston Valley Hospital Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Christopher Metzger    423-230-5640    research@mycva.com   
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01901289     History of Changes
Other Study ID Numbers: 12-004
Study First Received: July 8, 2013
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
Peripheral Vascular Disease
Femoral Artery
Popliteal Artery
Drug-Eluting Stent

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014