Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

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

The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)

Detailed Description

The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below:

1. Endologix unibody bifurcated stent graft
2. Endologix fenestrated proximal extension stent graft
3. Endologix renal stent graft

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Hospital Universidad Catolica
• France
  • Creteil, France, 94000
    • Bureau de Recherche Clinique
• Netherlands
  • Arnhem, Netherlands, 6800
    • Rijnstate Hospital
• New Zealand
  • Auckland, New Zealand, 1032
    • Auckland City Hospital
• United Kingdom
  • London, United Kingdom, SW17 0RE
    • St. George's Vascular Institute
• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • University of Indiana
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

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

Description

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

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
Other: Single Arm; All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.	Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System); Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System; Other Names: Ventana; Xpand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint	Major adverse events defined as: All-cause death; Bowel ischemia; Myocardial infarction; Paraplegia; Renal failure; Respiratory failure; Stroke; Blood loss >=1,000cc	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility/Effectiveness	Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak.; Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak; Procedural Technical Success is defined as a subject with successful implant.; Aneurysm Rupture: An aneurysm is a balloon-like bulge of an artery wall. As an aneurysm grows it puts pressure on nearby structures and may eventually rupture.; Clinically Significant Device Migration: Core Lab reported aortic stent graft movement >10mm; Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV).; Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).	1 Year
Procedural/In-hospital Evaluations	Fluoroscopy time, Renal Artery Cannulation time and procedure time	Procedurally and to hospital discharge
Mortality	All-cause and aneurysm-related	Procedurally and to 5 Years
Major Adverse Events	All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss >1,000cc	>30 Days to 5 Years
Number of Participants With Renal Dysfunction	Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR>=60 and Renal Dysfunction In subjects with baseline eGFR <60	30 Days, 6 Months and Years 1 to 5
Aneurysm Rupture	Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure	Procedurally and to 5 Years
Conversion to Open Repair	Open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason	Procedurally and to 5 Years
Device Integrity	Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression	30 Days, 6 Months, and Years 1 to 5
Stent Graft Patency	Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion	30 Days, 6 Months, and Years 1 to 5
Aneurysm Diameter Change	Change in aneurysm sac diameter - decrease > 5mm, Increase > 5mm, Stable (+/- 5mm) and No growth.	6 Months, and Years 1 to 5
Secondary Procedures	Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect.	30 Days, 6 Month and Years 1 to 5
Procedural/In-hospital Evaluations	Contrast volume and estimated blood loss	Procedurally and to hospital discharge
Procedural/In-hospital Evaluations	Time to hospital discharge	Discharge

Collaborators and Investigators

• Sponsor: Endologix
• Investigators: Principal Investigator: Andrew Holden, MD, Auckland City Hospital; Principal Investigator: Renato Mertens, MD, Hospital Universidad Catolica

Publications and helpful links

General Publications

• Mertens R, Bergoeing M, Marine L, Valdes F, Kramer A, Vergara J. Ventana fenestrated stent-graft system for endovascular repair of juxtarenal aortic aneurysms. J Endovasc Ther. 2012 Apr;19(2):173-8. doi: 10.1583/11-3706.1.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (Estimate): May 5, 2011

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Renal; Juxtarenal; Fenestrated; Pararenal; Abdominal Aortic Aneurysm; Endologix; Renal Stent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CP-0003