Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
This study is currently recruiting participants.
Verified January 2013 by Cook
Sponsor:
Cook
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01540643
First received: February 23, 2012
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.
| Condition | Intervention |
|---|---|
|
Abdominal Aortic Aneurysm Aorto-iliac Aneurysm |
Device: Iliac Leg Graft |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry |
Resource links provided by NLM:
Further study details as provided by Cook:
Primary Outcome Measures:
- Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Abdominal aortic aneurysm |
Device: Iliac Leg Graft
Zenith® Spiral-Z® AAA Iliac Leg Graft
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients implanted with an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft
Criteria
Inclusion Criteria:
- Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg Graft.
Exclusion Criteria:
- Patients for whom this device would not normally be considered standard of care.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540643
Locations
| United States, Alabama | |
| Valley Vascular Consultants | Recruiting |
| Huntsville, Alabama, United States, 35801 | |
| Contact: Ronny Johnson, MD 256-265-7480 ronny.johnson@hhsys.org | |
| United States, Colorado | |
| University of Colorado, Anschutz Medical Campus | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Omid Jazaeri, MD 303-724-2690 omid.jazaeri@ucdenver.edu | |
| United States, Florida | |
| University of Miami Hospital | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Arash Bornak, MD 215-279-3724 abornak@med.miami.edu | |
| United States, Missouri | |
| Mercy Hospital Springfield | Recruiting |
| Springfield, Missouri, United States, 65804 | |
| Contact: Sirish Parvathaneni 417-820-3960 Sirish.parvathaneni@mercy.net | |
| United States, New Jersey | |
| Robert Wood Johnson University Hospital | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Saum Rahimi, MD rahimisa@umdnj.edu | |
| United States, New York | |
| Albany Medical Center Hospital | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact: Manish Mehta, MD 518-218-7108 mehtam@albanyvascular.com | |
| Westchester Medical Center | Recruiting |
| Hawthorne, New York, United States, 10532 | |
| Contact: Igor Laskowski, MD 914-593-1200 Laskowskii@wcmc.com | |
| Mount Sinai Hospital | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Sharif Ellozy 212-241-0756 sharif.ellozy@mountsinai.org | |
| United States, Ohio | |
| Mount Carmel East | Recruiting |
| Columbus, Ohio, United States, 43213 | |
| Contact: Aaron Kulwicki, MD 614-353-6191 aaronkulwicki@hotmail.com | |
| United States, Tennessee | |
| Physican's Regional Medical Center | Recruiting |
| Knoxville, Tennessee, United States, 37909 | |
| Contact: Donald Akers, MD 865-306-5716 dakers@premiersurgical.com | |
| United States, Washington | |
| Providence Regional Medical Center Everett | Recruiting |
| Everett, Washington, United States, 98201 | |
| Contact: Mark Papenhausen 425-297-5200 mpapenhausen@radiax.com | |
| United States, West Virginia | |
| Charleston Area Medical Center | Recruiting |
| Charleston, West Virginia, United States, 25304 | |
| Contact: Patrick Stone, MD 304-881-2935 pstone0627@yahoo.com | |
| Canada, Ontario | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Thomas Forbes, MD 519-667-6794 tom.forbes@lhsc.on.ca | |
| Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Contact: Thomas Lindsay, MD 416-340-4800 ext 4620 thomas.lindsay@uhn.ca | |
Sponsors and Collaborators
Cook
Investigators
| Principal Investigator: | Manish Mehta, MD | Albany Medical Center Hospital |
More Information
No publications provided
| Responsible Party: | Cook |
| ClinicalTrials.gov Identifier: | NCT01540643 History of Changes |
| Other Study ID Numbers: | 11-015 |
| Study First Received: | February 23, 2012 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Cook:
|
abdominal aortic aneurysm iliac leg graft |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Iliac Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013