34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

NCT00706394 | Completed Results DMC

• 1 other identifier: CP03-023
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 10

Brief Summary

Study of anatomical fixation with a 34mm proximal extension

Conditions

Abdominal Aortic Aneurysm

Keywords

Powerlink; 34mm; Abdominal Aortic Aneurysm; EVAR

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Proximal Type I Endoleak at Each Timepoint

  Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).

  Five years

Secondary Outcomes (9)

• Number of Participants With Successful Delivery and Deployment of the Device

  1 Month

• Number of Participants With Type III Endoleaks at Each Timepoint

  5 Years

• Number of Participants With Stent Fracture at Each Timepoint

  5 Years

• Number of Participants With Stent Graft Obstruction at Each Timepoint

  5 Years

• Number of Participants With Migration at Each Timepoint

  5 Years

Study Arms (1)

A

EXPERIMENTAL

Powerlink 34mm cuff stent graft

Device: Endologix Powerlink 34 mm stent graft cuff

Interventions

Endologix Powerlink 34 mm stent graft cuff DEVICE

Endovascular abdominal aortic aneurysm repair

Also known as: Endologix Powerlink 34mm cuff [model 34-34-80L]

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endologix: lead

Study Sites (10)

Mount Sinai Medical Center

Miami, Florida, 33140, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Baptist Hospital East

Louisville, Kentucky, 40207, United States

Location

St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Sisters of Charity Hospital

Buffalo, New York, 14214, United States

Location

Oklahoma Cardiovascular Associates

Oklahoma City, Oklahoma, 73120, United States

Location

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

Related Publications (1)

• 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.

  PMID: 19679425 RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Sharone Trifskin
• Organization: Endologix

strifskin@endologix.com

949-599-8860

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: June 27, 2008
• Study Start: August 10, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 1, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-10

Locations

US (10)