34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
This study is ongoing, but not recruiting participants.
Sponsor:
Endologix
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT00706394
First received: May 2, 2008
Last updated: September 12, 2011
Last verified: September 2011
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Purpose
Study of anatomical fixation with a 34mm proximal extension
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Aortic Aneurysm |
Device: Endologix Powerlink 34 mm stent graft cuff |
Phase 2 Phase 3 |
Endologix has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| 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: | Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms |
Resource links provided by NLM:
Further study details as provided by Endologix:
Primary Outcome Measures:
- Proximal Type I endoleak [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Delivery success, deployment success, stent graft apposition to the vessel wall, device integrity, patency, occlusion, migration and Type III endoleak. [ Time Frame: One year ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Powerlink 34mm cuff stent graft
|
Device: Endologix Powerlink 34 mm stent graft cuff
Endovascular abdominal aortic aneurysm repair
Other Name: Endologix Powerlink 34mm cuff [model 34-34-80L]
|
Detailed Description:
The 34mm proximal 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years old or older
- Informed consent understood and signed
- Will comply with protocol follow-up requirements
- Candidate for conventional open surgical repair
Aneurysm outer diameter is one or more of the following:
- greater than or equal to 4.0cm
- greater than or equal to 3.0cm (saccular aneurysm)
- greater than or equal to twice the normal aortic outer diameter
- rapidly growing (greater than or equal to 5mm over 6 months)
- Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
- Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
- Iliac artery internal diameter greater than or equal to 8 mm
Exclusion Criteria:
- Life expectancy <2 years
- Participating in another clinical study
- Pregnant or lactating women
- Acutely ruptured/leaking aneurysm
- Traumatic vascular injury
- Other medical or psychiatric problems
- Contraindication to non-ionic contrast media or anticoagulants
- Coagulopathy or bleeding disorder
- Active systemic or localized groin infection
- Indispensable inferior mesenteric artery
- Connective tissue disease (e.g., Marfan's Syndrome)
- Creatinine level >1.7 mg/dl
- Renal transplant patient
- Proximal attachment site >60º angle to the aneurysm body
- Iliac arteries >90º angle
- <1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides [One internal iliac artery is required to remain patent]
- Thrombus >30% at implantation site
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706394
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 | |
Sponsors and Collaborators
Endologix
Investigators
| 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
Publications:
| Responsible Party: | Endologix |
| ClinicalTrials.gov Identifier: | NCT00706394 History of Changes |
| Other Study ID Numbers: | CP03-023 |
| Study First Received: | May 2, 2008 |
| Last Updated: | September 12, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Endologix:
|
Powerlink 34mm Abdominal Aortic Aneurysm EVAR |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013