34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: Endologix Powerlink 34 mm stent graft cuff

• Registration Number: NCT00706394
• Lead Sponsor: Endologix

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.

Study Timeline

• Study Start: 2007-08-10
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-06-26
• Study First Posted: 2008-06-27
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Results First Submitted: 2021-09-23
• Results First Submitted QC: 2021-09-23
• Status Verified: 2021-10
• Results First Posted: 2021-10-20
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Endologix Powerlink 34 mm stent graft cuff	Powerlink 34mm cuff stent graft

Primary Outcome Measures

Name	Time	Method
Number of Participants With Proximal Type I Endoleak at Each Timepoint	Five years	Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Type III Endoleaks at Each Timepoint	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.
Maximum Diameter Measurements	5 Years	Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).
Number of Participants With Aneurysm Diameter Change at Each Timepoint	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.
Number of Participants With Migration at Each Timepoint	5 Years	Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.
Aneurysm Volume Measurements	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.
Number of Participants With Stent Fracture at Each Timepoint	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.
Number of Participants With Stent Graft Obstruction at Each Timepoint	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.
Number of Participants With Type II Endoleaks at Each Timepoint	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.
Number of Participants With Successful Delivery and Deployment of the Device	1 Month	Successful delivery and deployment of the device with no complication.

Trial Locations

Locations (10)

Baptist Hospital East; 🇺🇸 Louisville, Kentucky, United States

Sisters of Charity Hospital; 🇺🇸 Buffalo, New York, United States

Lexington Medical Center; 🇺🇸 West Columbia, South Carolina, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Nebraska Heart Institute; 🇺🇸 Lincoln, Nebraska, United States

Hospital at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Joseph Medical Center; 🇺🇸 Towson, Maryland, United States

Mount Sinai Medical Center; 🇺🇸 Miami, Florida, United States

Baptist Cardiac and Vascular Institute; 🇺🇸 Miami, Florida, United States

Oklahoma Cardiovascular Associates; 🇺🇸 Oklahoma City, Oklahoma, United States