Clinical trial NCT00706394: 34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
Official title: Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Powerlink
34mm
Abdominal Aortic Aneurysm
EVAR
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of anatomical fixation with a 34mm proximal extension

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 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

Primary outcomes:
measure: Number of Participants With Proximal Type I Endoleak at Each Timepoint
timeFrame: Five years
Secondary outcomes:
measure: Number of Participants With Successful Delivery and Deployment of the Device
timeFrame: 1 Month
measure: Number of Participants With Type III Endoleaks at Each Timepoint
timeFrame: 5 Years
measure: Number of Participants With Stent Fracture at Each Timepoint
timeFrame: 5 Years
measure: Number of Participants With Stent Graft Obstruction at Each Timepoint
timeFrame: 5 Years
measure: Number of Participants With Migration at Each Timepoint
timeFrame: 5 Years
measure: Number of Participants With Type II Endoleaks at Each Timepoint
timeFrame: 5 Years
measure: Number of Participants With Aneurysm Diameter Change at Each Timepoint
timeFrame: 5 Years
measure: Maximum Diameter Measurements
timeFrame: 5 Years
measure: Aneurysm Volume Measurements
timeFrame: 5 Years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Louisville
country: United States
facility: Baptist Hospital East
state: Kentucky
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Buffalo
country: United States
facility: Sisters of Charity Hospital
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Associates
state: Oklahoma
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
Study officials:
affiliation: Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States
name: Edward Y Woo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: William Beaumont Hospital, Royal Oak, MI 48073, United States
name: O. W. Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Cardiovascular Research Group, Oklahoma City, OK 73120, United States
name: James G. Melton, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Nebraska Heart Hospital, Lincoln, NE 68526, United States
name: Steven H. Tyndall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lexington Medical Center, West Columbia, SC 29169, United States
name: William M. Moore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital East, Louisville, KY 40207, United States
name: Salem George, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph Medical Center, Towson, MD 21204, United States
name: Kerry C. Prewitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sisters of Charity Hospital, Buffalo, NY 14214, United States
name: Paul Anain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Medical Center, Miami Beach, FL 33140, United States
name: Robert Beasley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Cardiac and Vascular Institute, Miami, FL 33176, United States
name: Barry T. Katzen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.