34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Study Overview
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Brief Summary
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Study of anatomical fixation with a 34mm proximal extension

Detailed Description
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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.

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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Endologix Powerlink 34 mm stent graft cuff


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Powerlink 34mm cuff stent graft | Device: Endologix Powerlink 34 mm stent graft cuff<br>* Endovascular abdominal aortic aneurysm repair<br>* Other names: Endologix Powerlink 34mm cuff [model 34-34-80L];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Delivery and Deployment of the Device | Successful delivery and deployment of the device with no complication. | 1 Month | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Maximum Diameter Measurements | Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months). | 5 Years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Powerlink, 34mm, Abdominal Aortic Aneurysm, EVAR