Pilot Study of the Endologix Fenestrated Stent Graft System

Not Applicable

Completed

• Conditions: Juxtarenal Aortic Aneurysm; Pararenal Aortic Aneurysm
• Interventions: Device: Ventana Fenestrated Stent Graft System

• Registration Number: NCT01437215
• Lead Sponsor: Endologix

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-02
• Primary Completion: 2011-09
• Study First Submitted: 2011-09-17
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Study Completion: 2016-07-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fenestrated Endografting	Ventana Fenestrated Stent Graft System	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, Chile