Pilot Study of the Endologix Fenestrated Stent Graft System

Prospective, Multicenter, Single Arm Feasibility and Initial Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms

The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.

Study Overview

• Status: Completed
• Conditions: Juxtarenal Aortic Aneurysm; Pararenal Aortic Aneurysm
• Intervention / Treatment: Device: Ventana Fenestrated Stent Graft System

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Pontificia Universidad Catolica de Chile
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent understood and signed and pt agrees to all follow-up visits;
• Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
• 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 at least 70mm
• Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) <60° to the aneurysm sac;
• Angle <60° (clock face) between the SMA and celiac artery
• Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
• Iliac anatomy suitable for commercial bifurcated stent graft;
• Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts

Exclusion Criteria:

• Life expectancy <1 year 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, dissecting, or mycotic aneurysm;
• 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 or myocardial infarction;
• Prior renal transplant;
• Length of either renal artery to be stented <13mm;
• Significant occlusive disease or calcification of either renal artery;
• 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 (female patient of childbearing potential only)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fenestrated Endografting	Device: Ventana Fenestrated Stent Graft System; Endovascular repair of juxtarenal or pararenal aortic aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Number of Major Adverse Events (MAEs)	Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc	30 Days
Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration	Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Number of Major Adverse Events (MAEs)	Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc	>30 Days to 5 Years
Adverse Events	All adverse events, whether serious or non-serious	Procedurally to 5 Years
Distal Blood Flow	Ankle-brachial index measurements	Discharge to 5 Years
Renal Dysfunction	eGFR reduction >30% from baseline	Discharge to 5 Years
Device Performance	Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology	30 Days to 5 Years

Collaborators and Investigators

• Sponsor: Endologix

Publications and helpful links

General Publications

• Holden A, Mertens R, Hill A, Marine L, Clair DG. Initial experience with the Ventana fenestrated system for endovascular repair of juxtarenal and pararenal aortic aneurysms. J Vasc Surg. 2013 May;57(5):1235-45. doi: 10.1016/j.jvs.2012.10.125. Epub 2013 Mar 5.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): July 28, 2016

Study Registration Dates

• First Submitted: September 17, 2011
• First Submitted That Met QC Criteria: September 19, 2011
• First Posted (Estimated): September 20, 2011

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: aneurysm; renal stent; juxtarenal; pararenal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: CP-0002