- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00706394
34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
October 22, 2021 updated by: Endologix
Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms
Study of anatomical fixation with a 34mm proximal extension
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
19
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
-
-
Florida
-
Miami, Florida, United States, 33176
- Baptist Cardiac and Vascular Institute
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Miami, Florida, United States, 33140
- Mount Sinai Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40207
- Baptist Hospital East
-
-
Maryland
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Towson, Maryland, United States, 21204
- St. Joseph Medical Center
-
-
Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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-
Nebraska
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Lincoln, Nebraska, United States, 68526
- Nebraska Heart Institute
-
-
New York
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Buffalo, New York, United States, 14214
- Sisters of Charity Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Oklahoma Cardiovascular Associates
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital at the University of Pennsylvania
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South Carolina
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West Columbia, South Carolina, United States, 29169
- Lexington Medical Center
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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 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
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: A
Powerlink 34mm cuff stent graft
|
Endovascular abdominal aortic aneurysm repair
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Proximal Type I Endoleak at Each Timepoint
Time Frame: Five years
|
Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).
|
Five years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Successful Delivery and Deployment of the Device
Time Frame: 1 Month
|
Successful delivery and deployment of the device with no complication.
|
1 Month
|
Number of Participants With Type III Endoleaks at Each Timepoint
Time Frame: 5 Years
|
Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
|
5 Years
|
Number of Participants With Stent Fracture at Each Timepoint
Time Frame: 5 Years
|
Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.
|
5 Years
|
Number of Participants With Stent Graft Obstruction at Each Timepoint
Time Frame: 5 Years
|
Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.
|
5 Years
|
Number of Participants With Migration at Each Timepoint
Time Frame: 5 Years
|
Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.
|
5 Years
|
Number of Participants With Type II Endoleaks at Each Timepoint
Time Frame: 5 Years
|
Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
|
5 Years
|
Number of Participants With Aneurysm Diameter Change at Each Timepoint
Time Frame: 5 Years
|
Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.
|
5 Years
|
Maximum Diameter Measurements
Time Frame: 5 Years
|
Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).
|
5 Years
|
Aneurysm Volume Measurements
Time Frame: 5 Years
|
Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.
|
5 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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.
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)
August 10, 2007
Primary Completion (ACTUAL)
September 1, 2013
Study Completion (ACTUAL)
September 1, 2013
Study Registration Dates
First Submitted
May 2, 2008
First Submitted That Met QC Criteria
June 26, 2008
First Posted (ESTIMATE)
June 27, 2008
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2021
Last Update Submitted That Met QC Criteria
October 22, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP03-023
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.
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