- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00739401
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
December 9, 2021 updated by: Endologix
Endologix Powerlink® Suprarenal Proximal Cuff
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami Beach, Florida, United States, 33140
- Mount Sinai Medical Center
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Ocala, Florida, United States, 34474
- Munroe Regional Medical Center
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Orlando, Florida, United States, 32806
- Orlando Regional Hospital
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Pensacola, Florida, United States, 32504
- Sacred Heart Hospital - Pensacola Research Consultants
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Illinois
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Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
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Indiana
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Evansville, Indiana, United States, 47710
- Deaconess Hospital - The Heart Group
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Hospital
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Greenville, North Carolina, United States, 27834
- East Carolina University - Brody School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
|
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Proximal Type I Endoleak
Time Frame: Within 30 Days
|
The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.
|
Within 30 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Major Adverse Events
Time Frame: Within 30 days
|
All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke
|
Within 30 days
|
Number of Participants With Stent Graft Integrity and Performance
Time Frame: 30 days
|
Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results
|
30 days
|
Endoleak
Time Frame: 30 days
|
Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak. Endoleak diagnosis results as reported by the Core Lab. |
30 days
|
Aneurysm Morphology Changes
Time Frame: 30 days
|
Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab.
|
30 days
|
Renal Function
Time Frame: 30 days
|
Renal function as measured by serum creatinine.
Laboratory results,
|
30 days
|
Aneurysm Morphology Changes
Time Frame: 30 days
|
Aneurysm morphology changes (Volume) as reported by CoreLab.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. doi: 10.1016/j.jvs.2005.09.025.
- Harlin SA, Beasley RE, Feldman RL, Thompson CS, Williams JB. Endovascular abdominal aortic aneurysm repair using an anatomical fixation technique and concomitant suprarenal orientation: results of a prospective, multicenter trial. Ann Vasc Surg. 2010 Oct;24(7):921-9. doi: 10.1016/j.avsg.2010.05.008.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 5, 2006
Primary Completion (ACTUAL)
August 1, 2008
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
August 19, 2008
First Submitted That Met QC Criteria
August 19, 2008
First Posted (ESTIMATE)
August 21, 2008
Study Record Updates
Last Update Posted (ACTUAL)
December 10, 2021
Last Update Submitted That Met QC Criteria
December 9, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP04-002
- IDE G990139 (OTHER: FDA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Aortic Aneurysm
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Assistance Publique - Hôpitaux de ParisUnknownSmall Abdominal Aortic Aneurysm | Abdominal Aortic Aneurysm,France
-
Karolinska University HospitalEnrolling by invitationAneurysm | Aortic Aneurysm | Abdominal Aortic Aneurysm, Ruptured | Aneurysm Abdominal | Abdominal Aortic Aneurysm Without RuptureSweden
-
EndologixActive, not recruiting1 Paravisceral Abdominal Aortic Aneurysm | 2 Juxtarenal Abdominal Aortic Aneurysm | 3 Pararenal Abdominal Aortic Aneurysm | 4 Complex Abdominal Aortic AneurysmsUnited States
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Medtronic CardiovascularCompletedAbdominal Aortic Aneurysms (AAA)United States
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Vascutek Ltd.TerminatedAbdominal Aortic Aneurysms (AAA)United Kingdom, Netherlands, Switzerland, Spain, Germany, Belgium, Sweden, Canada, France, Italy, Austria, Monaco
-
Timothy Chuter, MDRecruitingThoracoabdominal Aortic Aneurysm | Paravisceral Abdominal Aortic AneurysmUnited States
-
Washington University School of MedicineRecruitingAbdominal Aortic Aneurysm (AAA) | No Abdominal Aortic Aneurysm (Non-AAA)United States
-
University of California, San DiegoRecruitingJuxtarenal Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm | Pararenal Aortic Aneurysm | Complex Abdominal Aortic AneurysmUnited States
-
Assistance Publique Hopitaux De MarseilleCompletedAbdominal Aortic AneurysmsFrance
-
Hangzhou Endonom Medtech Co., Ltd.RecruitingJuxtarenal Abdominal Aortic AneurysmChina
Clinical Trials on Suprarenal Proximal Cuff Extension
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Cairo UniversityUnknown
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Ain Shams UniversityActive, not recruiting