Abdominal Aortic Aneurysm Clinical Trial
Official title:
Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
| Verified date | January 2017 |
| Source | Cook |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hamilton General Hospital | Hamilton | Ontario |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | Ottawa Hospital Civic Campus | Ottawa | Ontario |
| Canada | Toronto General Hospital | Toronto | Ontario |
| United States | Albany Medical Center Hospital | Albany | New York |
| United States | University Hospital | Augusta | Georgia |
| United States | University of Colorado, Anschutz Medical Campus | Aurora | Colorado |
| United States | Bend Memorial Clinic | Bend | Oregon |
| United States | St. Luke's University Hospital | Bethlehem | Pennsylvania |
| United States | St. Vincent's Heart and Vascular Center | Billings | Montana |
| United States | Charleston Area Medical Center | Charleston | West Virginia |
| United States | Missouri Heart Center | Columbia | Missouri |
| United States | Mount Carmel East | Columbus | Ohio |
| United States | Providence Regional Medical Center Everett | Everett | Washington |
| United States | University of Florida | Gainesville | Florida |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Hartford Hospital | Hartford | Connecticut |
| United States | Westchester Medical Center | Hawthorne | New York |
| United States | Houston VA | Houston | Texas |
| United States | Valley Vascular Consultants | Huntsville | Alabama |
| United States | Physican's Regional Medical Center | Knoxville | Tennessee |
| United States | University of Miami Hospital | Miami | Florida |
| United States | Mount Sinai Medical Center | Miami Beach | Florida |
| United States | Froedert Hospital | Milwaukee | Wisconsin |
| United States | Morristown Medical Center | Morristown | New Jersey |
| United States | Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
| United States | Mount Sinai Hospital | New York | New York |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | University of Utah Hospital | Salt Lake City | Utah |
| United States | Mercy Hospital Springfield | Springfield | Missouri |
| United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Cook |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft. | 12 months |
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