Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01348828
• Date of registration: 03/05/2011
• Prospective Registration: Yes
• Primary sponsor: Endologix
• Public title: Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
• Scientific title: Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
• Date of first enrolment: November 2011
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01348828
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Chile, France, Netherlands, New Zealand, United Kingdom, United States

Contacts

• Name: Andrew Holden, MD
• Affiliation: Auckland City Hospital

• Name: Renato Mertens, MD
• Affiliation: Hospital Universidad Catolica

• Name: Daniel Clair, MD
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adequate iliac/femoral access compatible with the required delivery systems

- Non-aneurysmal infrarenal aortic neck <15mm in length

- Most caudal renal artery to aortoiliac bifurcation length >= 70

- SMA to aortoiliac bifurcation length >=90mm

- Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length
>=15mm and angle <=60° to the aneurysm sac

- Angle <=60° (clock face) between the SMA and CA

- Renal arteries both at or below the SMA by <=35mm and within 30mm of each other
axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to
each other

- Common iliac artery distal fixation site with: distal fixation length >=15mm, with
diameter >=10 mm and <=23 mm and angle <=90° to the aortic bifurcation

- Ability to preserve at least one hypogastric artery

Exclusion Criteria:

- Life expectancy <2 years as judged by the investigator

- Psychiatric or other condition that may interfere with the study

- Participating in the enrollment or 30-day follow-up phase of another clinical study

- Known allergy to any device component

- Coagulopathy or uncontrolled bleeding disorder

- Contraindication to contrast media or anticoagulants

- Ruptured, leaking, or mycotic aneurysm

- Aortic dissection Serum creatinine (S-Cr) level >2.0 mg/dL

- Traumatic vascular injury

- Active systemic or localized groin infection

- Connective tissue disease (e.g., Marfan's Syndrome)

- Recent(within prior three months)cerebrovascular accident

- Recent(within prior three months)myocardial infarction

- Prior renal transplant

- Length of either renal artery to be stented <12mm

- Significant occlusive disease or calcification of either renal artery (>70%)

- An essential accessory renal artery

- Indispensable inferior mesenteric artery

- Untreated aneurysmal disease of the descending thoracic aorta

- Clinically significant mural thrombus circumferentially in the suprarenal segment

- Prior iliac artery stent implanted that may interfere with delivery system
introduction

- Unsuitable vascular anatomy

- Pregnancy



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Abdominal Aortic Aneurysm

Intervention(s)

Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)

Primary Outcome(s)

Primary Safety Endpoint [Time Frame: 30 days]

Secondary Outcome(s)

Endograft Performance [Time Frame: 30 Days, 6 Months, and Years 1 to 5]

Renal Stent Graft Patency and Integrity [Time Frame: 30 Days, 6 Months, and Years 1 to 5]

Major Adverse Events [Time Frame: >30 Days to 5 Years]

Feasibility/effectiveness [Time Frame: 30 Days]

Adverse Events [Time Frame: Procedurally and to 5 Years]

Aneurysm Rupture [Time Frame: Procedurally and to 5 Years]

Secondary Procedures [Time Frame: 30 Days, 6 Months, and Years 1 to 5]

Stent Graft Patency and Integrity [Time Frame: 30 Days, 6 Months, and Years 1 to 5]

Conversion to Open Repair [Time Frame: Procedurally and to 5 Years]

Mortality [Time Frame: Procedurally and to 5 Years]

Distal Blood Flow [Time Frame: Pre-discharge, 30 Days, 6 Months, and Years 1 to 5]

Procedural/in-hospital evaluations [Time Frame: Procedurally and to hospital discharge]

Renal Dysfunction [Time Frame: 30 Days, 6 Months and Years 1 to 5]

Secondary ID(s)

CP-0003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors