34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Endologix

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: Endologix Powerlink 34 mm stent graft cuff

Study type: Interventional

Funder types: Industry

Identifiers

NCT00706394

CP03-023

Details and patient eligibility

About

Study of anatomical fixation with a 34mm proximal extension

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

A

Experimental group

Description:

Powerlink 34mm cuff stent graft

Treatment:

Device: Endologix Powerlink 34 mm stent graft cuff