34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706394
• Other study ID #: CP03-023
• Status: Completed
• Phase: N/A
• Start date: August 10, 2007
• Est. completion date: September 2013

Study information

• Verified date: October 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of anatomical fixation with a 34mm proximal extension

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Endologix Powerlink 34 mm stent graft cuff
Endovascular abdominal aortic aneurysm repair

Locations

Country	Name	City	State
United States	Sisters of Charity Hospital	Buffalo	New York
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Baptist Hospital East	Louisville	Kentucky
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	Mount Sinai Medical Center	Miami	Florida
United States	Oklahoma Cardiovascular Associates	Oklahoma City	Oklahoma
United States	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	St. Joseph Medical Center	Towson	Maryland
United States	Lexington Medical Center	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Country where clinical trial is conducted

United States, 

References & 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: — View Citation

Outcome

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