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Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
Sponsored by
Endologix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Abdominal Aortic Aneurysm, Fenestrated, Renal Stent, Juxtarenal, Pararenal, Endologix, Renal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA
  • University of Indiana
  • Cleveland Clinic Foundation
  • Hospital Universidad Catolica
  • Bureau de Recherche Clinique
  • Rijnstate Hospital
  • Auckland City Hospital
  • St. George's Vascular Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Procedural/In-hospital Evaluations
Fluoroscopy time, Renal Artery Cannulation time and procedure time
Mortality
All-cause and aneurysm-related
Major Adverse Events
All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss >1,000cc
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
Aneurysm Rupture
Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
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
Device Integrity
Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression
Stent Graft Patency
Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion
Aneurysm Diameter Change
Change in aneurysm sac diameter - decrease > 5mm, Increase > 5mm, Stable (+/- 5mm) and No growth.
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.
Procedural/In-hospital Evaluations
Contrast volume and estimated blood loss
Procedural/In-hospital Evaluations
Time to hospital discharge

Full Information

First Posted
May 3, 2011
Last Updated
September 20, 2021
Sponsor
Endologix
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1. Study Identification

Unique Protocol Identification Number
NCT01348828
Brief Title
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2011 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
March 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endologix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below: Endologix unibody bifurcated stent graft Endologix fenestrated proximal extension stent graft Endologix renal stent graft

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
Abdominal Aortic Aneurysm, Fenestrated, Renal Stent, Juxtarenal, Pararenal, Endologix, Renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
Other Intervention Name(s)
Ventana, Xpand
Intervention Description
Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
Major adverse events defined as: All-cause death Bowel ischemia Myocardial infarction Paraplegia Renal failure Respiratory failure Stroke Blood loss >=1,000cc
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Feasibility/Effectiveness
Description
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).
Time Frame
1 Year
Title
Procedural/In-hospital Evaluations
Description
Fluoroscopy time, Renal Artery Cannulation time and procedure time
Time Frame
Procedurally and to hospital discharge
Title
Mortality
Description
All-cause and aneurysm-related
Time Frame
Procedurally and to 5 Years
Title
Major Adverse Events
Description
All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss >1,000cc
Time Frame
>30 Days to 5 Years
Title
Number of Participants With Renal Dysfunction
Description
Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR>=60 and Renal Dysfunction In subjects with baseline eGFR <60
Time Frame
30 Days, 6 Months and Years 1 to 5
Title
Aneurysm Rupture
Description
Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
Time Frame
Procedurally and to 5 Years
Title
Conversion to Open Repair
Description
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
Time Frame
Procedurally and to 5 Years
Title
Device Integrity
Description
Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression
Time Frame
30 Days, 6 Months, and Years 1 to 5
Title
Stent Graft Patency
Description
Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion
Time Frame
30 Days, 6 Months, and Years 1 to 5
Title
Aneurysm Diameter Change
Description
Change in aneurysm sac diameter - decrease > 5mm, Increase > 5mm, Stable (+/- 5mm) and No growth.
Time Frame
6 Months, and Years 1 to 5
Title
Secondary Procedures
Description
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.
Time Frame
30 Days, 6 Month and Years 1 to 5
Title
Procedural/In-hospital Evaluations
Description
Contrast volume and estimated blood loss
Time Frame
Procedurally and to hospital discharge
Title
Procedural/In-hospital Evaluations
Description
Time to hospital discharge
Time Frame
Discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Clair, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Holden, MD
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renato Mertens, MD
Organizational Affiliation
Hospital Universidad Catolica
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hospital Universidad Catolica
City
Santiago
Country
Chile
Facility Name
Bureau de Recherche Clinique
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6800
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1032
Country
New Zealand
Facility Name
St. George's Vascular Institute
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22545881
Citation
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.
Results Reference
derived

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Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

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