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| Sponsored by: |
Endologix |
| Information provided by: | Endologix |
| ClinicalTrials.gov Identifier: | NCT00706394 |
Purpose
The 34mm proximal cuff extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.
| Condition | Intervention | Phase |
|
Abdominal Aortic Aneurysm |
Device: Endologix Powerlink 34 mm stent graft cuff |
Phase II Phase III |
| MedlinePlus related topics: | Aneurysms |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms |
| Enrollment: | 60 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A: Experimental
Powerlink 34mm cuff stent graft
|
Device: Endologix Powerlink 34 mm stent graft cuff
Endovascular abdominal aortic aneurysm repair
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Aneurysm outer diameter is one or more of the following:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |||||
| Baptist Cardiac and Vascular Institute | |||||
| Miami, Florida, United States, 33176 | |||||
| Mount Sinai Medical Center | |||||
| Miami, Florida, United States, 33140 | |||||
| United States, Kentucky | |||||
| Baptist Hospital East | |||||
| Louisville, Kentucky, United States, 40207 | |||||
| United States, Maryland | |||||
| St. Joseph Medical Center | |||||
| Towson, Maryland, United States, 21204 | |||||
| United States, Michigan | |||||
| William Beaumont Hospital | |||||
| Royal Oak, Michigan, United States, 48073 | |||||
| United States, Nebraska | |||||
| Nebraska Heart Institute | |||||
| Lincoln, Nebraska, United States, 68526 | |||||
| United States, New York | |||||
| Sisters of Charity Hospital | |||||
| Buffalo, New York, United States, 14214 | |||||
| United States, Oklahoma | |||||
| Oklahoma Cardiovascular Associates | |||||
| Oklahoma City, Oklahoma, United States, 73120 | |||||
| United States, Pennsylvania | |||||
| Hospital at the University of Pennsylvania | |||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| United States, South Carolina | |||||
| Lexington Medical Center | |||||
| West Columbia, South Carolina, United States, 29169 | |||||
| Endologix |
| Principal Investigator: | Edward Y Woo, MD | Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States |
| Principal Investigator: | O. W. Brown, MD | William Beaumont Hospital, Royal Oak, MI 48073, United States |
| Principal Investigator: | James G. Melton, DO | Oklahoma Cardiovascular Research Group, Oklahoma City, OK 73120, United States |
| Principal Investigator: | Steven H. Tyndall, MD | Nebraska Heart Hospital, Lincoln, NE 68526, United States |
| Principal Investigator: | William M. Moore, MD | Lexington Medical Center, West Columbia, SC 29169, United States |
| Principal Investigator: | Salem George, MD | Baptist Hospital East, Louisville, KY 40207, United States |
| Principal Investigator: | Kerry C. Prewitt, MD | St. Joseph Medical Center, Towson, MD 21204, United States |
| Principal Investigator: | Paul Anain, MD | Sisters of Charity Hospital, Buffalo, NY 14214, United States |
| Principal Investigator: | Robert Beasley, MD | Mount Sinai Medical Center, Miami Beach, FL 33140, United States |
| Principal Investigator: | Barry T. Katzen, MD | Baptist Cardiac and Vascular Institute, Miami, FL 33176, United States |
More Information
| Responsible Party: | Endologix ( Janet Fauls / VP, Regulatory, Quality, and Clinical Affairs ) |
| Study ID Numbers: | CP03-023 |
| First Received: | May 2, 2008 |
| Last Updated: | June 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00706394 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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