This trial is active, not recruiting.

Condition abdominal aortic aneurysm
Treatment endologix powerlink 34 mm stent graft cuff
Phase phase 2/phase 3
Sponsor Endologix
Start date September 2005
End date September 2012
Trial size 60 participants
Trial identifier NCT00706394, CP03-023


Study of anatomical fixation with a 34mm proximal extension

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Powerlink 34mm cuff stent graft
endologix powerlink 34 mm stent graft cuff Endologix Powerlink 34mm cuff [model 34-34-80L]
Endovascular abdominal aortic aneurysm repair

Primary Outcomes

Proximal Type I endoleak
time frame: One year

Secondary Outcomes

Delivery success, deployment success, stent graft apposition to the vessel wall, device integrity, patency, occlusion, migration and Type III endoleak.
time frame: One year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms
Principal investigator Edward Y Woo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Endologix.