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34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

NCT ID: NCT00706394

Last Updated: 2021-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-10

Study Completion Date

2013-09-30

Brief Summary

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Study of anatomical fixation with a 34mm proximal extension

Detailed Description

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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.

Conditions

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Abdominal Aortic Aneurysm

Keywords

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Powerlink 34mm Abdominal Aortic Aneurysm EVAR

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Powerlink 34mm cuff stent graft

Group Type EXPERIMENTAL

Endologix Powerlink 34 mm stent graft cuff

Intervention Type DEVICE

Endovascular abdominal aortic aneurysm repair

Interventions

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Endologix Powerlink 34 mm stent graft cuff

Endovascular abdominal aortic aneurysm repair

Intervention Type DEVICE

Other Intervention Names

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Endologix Powerlink 34mm cuff [model 34-34-80L]

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endologix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Y Woo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States

O. W. Brown, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospital, Royal Oak, MI 48073, United States

James G. Melton, DO

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Cardiovascular Research Group, Oklahoma City, OK 73120, United States

Steven H. Tyndall, MD

Role: PRINCIPAL_INVESTIGATOR

Nebraska Heart Hospital, Lincoln, NE 68526, United States

William M. Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Lexington Medical Center, West Columbia, SC 29169, United States

Salem George, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Hospital East, Louisville, KY 40207, United States

Kerry C. Prewitt, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph Medical Center, Towson, MD 21204, United States

Paul Anain, MD

Role: PRINCIPAL_INVESTIGATOR

Sisters of Charity Hospital, Buffalo, NY 14214, United States

Robert Beasley, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Medical Center, Miami Beach, FL 33140, United States

Barry T. Katzen, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Cardiac and Vascular Institute, Miami, FL 33176, United States

Locations

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Mount Sinai Medical Center

Miami, Florida, United States

Site Status

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Site Status

Baptist Hospital East

Louisville, Kentucky, United States

Site Status

St. Joseph Medical Center

Towson, Maryland, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Nebraska Heart Institute

Lincoln, Nebraska, United States

Site Status

Sisters of Charity Hospital

Buffalo, New York, United States

Site Status

Oklahoma Cardiovascular Associates

Oklahoma City, Oklahoma, United States

Site Status

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Lexington Medical Center

West Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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Jordan WD Jr, Moore WM Jr, Melton JG, Brown OW, Carpenter JP; Endologix Investigators. Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg. 2009 Nov;50(5):979-86. doi: 10.1016/j.jvs.2009.05.057. Epub 2009 Aug 12.

Reference Type RESULT
PMID: 19679425 (View on PubMed)

Other Identifiers

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CP03-023

Identifier Type: -

Identifier Source: org_study_id