Pilot Study of the Endologix Fenestrated Stent Graft System

Juxtarenal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437215
• Other study ID #: CP-0002
• Status: Completed
• Phase: N/A
• Start date: November 2, 2010
• Est. completion date: July 28, 2016

Study information

• Verified date: February 2024
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 28, 2016
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Juxtarenal Aortic Aneurysm
• Pararenal Aortic Aneurysm

Intervention

Device:
• Ventana Fenestrated Stent Graft System
Endovascular repair of juxtarenal or pararenal aortic aneurysm

Locations

Country	Name	City	State
Chile	Pontificia Universidad Católica de Chile	Santiago
New Zealand	Auckland City Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Countries where clinical trial is conducted

Chile,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Adverse Events	All adverse events, whether serious or non-serious	Procedurally to 5 Years
Secondary	Distal Blood Flow	Ankle-brachial index measurements	Discharge to 5 Years
Secondary	Renal Dysfunction	eGFR reduction >30% from baseline	Discharge to 5 Years
Secondary	Device Performance	Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology	30 Days to 5 Years