Trial record 45 of 108 for:    johnstown

Fenestrated AAA Endovascular Graft Post-Approval Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01990950
First received: November 18, 2013
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.


Condition Intervention
Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Juxtarenal Aneurysm
Device: Zenith® Fenestrated AAA Endovascular Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated AAA Endovascular Graft Post-Approval Study

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Treatment success : AAA related mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: March 2014
Estimated Study Completion Date: April 2024
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zenith® Fenestrated AAA Endovascular Graft Device: Zenith® Fenestrated AAA Endovascular Graft
The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair

  Eligibility

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

Inclusion Criteria:

  • abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
  • aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair

Exclusion Criteria:

  • proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
  • renal artery stenosis greater than 50 percent
  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: NCT01990950

Contacts
Contact: Amy M Griggs, PhD 765-463-7537 agriggs@medinst.com

Locations
United States, California
University of California-Davis Not yet recruiting
Sacramento, California, United States, 95817
Contact: David Dawson, MD    916-734-3800    david.dawson@ucdmc.ucdavis.edu   
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Omid Jazaeri, MD    303-724-2690    Omid.jazaeri@ucdenver.edu   
United States, Michigan
Borgess Research Institute Recruiting
Kalamazoo, Michigan, United States, 49048
Contact: Daniel Johnston, MD    269-492-6500    djohnston@avsurgery.com   
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Bruce Brener, MD    201-206-7925    bbrener@barnabashealth.org   
United States, North Carolina
Wake Forest University Health Recruiting
Winston-Salem, North Carolina, United States, 27102
Contact: Justin Hurie    336-970-3781    jhurie@wakehealth.edu   
United States, Pennsylvania
Conemaugh Valley Memorial Hospital Not yet recruiting
Johnstown, Pennsylvania, United States, 15906
Contact: James Tretter, DO    814-534-9194    jtretter@conemaugh.org   
United States, Wisconsin
University of Wisconsin Hospital and Clinics Not yet recruiting
Madison, Wisconsin, United States, 53711
Contact: Girma Tefera, M.D.    608-265-4420    Tefera@surgery.wisc.edu   
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01990950     History of Changes
Other Study ID Numbers: 11-005
Study First Received: November 18, 2013
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Aneurysm
Aortic Aneurysm
Iliac Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on October 19, 2014