Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
This study is ongoing, but not recruiting participants.
Sponsor:
Endologix
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT00739401
First received: August 19, 2008
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Aortic Aneurysm |
Device: Suprarenal Proximal Cuff Extension |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Endologix Powerlink® Suprarenal Proximal Cuff |
Resource links provided by NLM:
Further study details as provided by Endologix:
Primary Outcome Measures:
- Proximal type I endoleak [ Time Frame: Within 30 Days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Major adverse events; delivery and deployment success, device integrity, patency, graft migration; and renal function. [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
|
Device: Suprarenal Proximal Cuff Extension
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years old
- Informed consent understood and signed
- Will comply with post-treatment follow-up requirements up to 5 years
- Candidate for Powerlink Infrarenal Bifurcated Graft
Exclusion Criteria:
- Life expectancy < 2 years
- Participating in another clinical research study
- Pregnant or lactating women
- Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study
- Creatinine level > 1.7mg/dl
- Renal transplant patient
- Patient with > 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739401
Locations
| United States, Florida | |
| Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Munroe Regional Medical Center | |
| Ocala, Florida, United States, 34474 | |
| Orlando Regional Hospital | |
| Orlando, Florida, United States, 32806 | |
| Sacred Heart Hospital - Pensacola Research Consultants | |
| Pensacola, Florida, United States, 32504 | |
| United States, Illinois | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| United States, Indiana | |
| Deaconess Hospital - The Heart Group | |
| Evansville, Indiana, United States, 47710 | |
| United States, North Carolina | |
| Duke University Hospital | |
| Durham, North Carolina, United States, 27710 | |
| East Carolina University - Brody School of Medicine | |
| Greenville, North Carolina, United States, 27834 | |
Sponsors and Collaborators
Endologix
Investigators
| Principal Investigator: | Robert Beasley, MD | Mount Sinai School of Medicine |
| Principal Investigator: | William M. Bogey, MD | East Carolina University - Brody School of Medicine |
| Principal Investigator: | Robert Feldman, MD | Munroe Regional Medical Center |
| Principal Investigator: | Stuart Harlin, MD | Sacred Heart Hospital - Pensacola Research |
| Principal Investigator: | Jeffrey Lawson, MD | Duke University |
| Principal Investigator: | William Moore, MD | Lexington Medical Center |
| Principal Investigator: | Charles Thompson, MD | Orlando Regional Medical Center |
| Principal Investigator: | Thomas E. Topper, MD | Deaconess Hospital - The Heart Group |
More Information
Additional Information:
Publications:
| Responsible Party: | Endologix |
| ClinicalTrials.gov Identifier: | NCT00739401 History of Changes |
| Other Study ID Numbers: | CP04-002, IDE G990139 |
| Study First Received: | August 19, 2008 |
| Last Updated: | September 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endologix:
|
AAA Aneurysm Suprarenal Proximal Cuff Extension |
Endograft Endovascular repair EVAR Endoleak Type I |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013