Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

September 20, 2021 updated by: Endologix

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: 30 days

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility/Effectiveness
Time Frame: 1 Year

Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak.

  1. Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak
  2. Procedural Technical Success is defined as a subject with successful implant.
  3. 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.
  4. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement >10mm
  5. 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).
  6. 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
Time Frame: Procedurally and to hospital discharge
Fluoroscopy time, Renal Artery Cannulation time and procedure time
Procedurally and to hospital discharge
Mortality
Time Frame: Procedurally and to 5 Years
All-cause and aneurysm-related
Procedurally and to 5 Years
Major Adverse Events
Time Frame: >30 Days to 5 Years
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
Time Frame: 30 Days, 6 Months and Years 1 to 5
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
Time Frame: Procedurally and to 5 Years
Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
Procedurally and to 5 Years
Conversion to Open Repair
Time Frame: Procedurally and to 5 Years
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
Time Frame: 30 Days, 6 Months, and Years 1 to 5
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
Time Frame: 30 Days, 6 Months, and Years 1 to 5
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
Time Frame: 6 Months, and Years 1 to 5
Change in aneurysm sac diameter - decrease > 5mm, Increase > 5mm, Stable (+/- 5mm) and No growth.
6 Months, and Years 1 to 5
Secondary Procedures
Time Frame: 30 Days, 6 Month and Years 1 to 5
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
Time Frame: Procedurally and to hospital discharge
Contrast volume and estimated blood loss
Procedurally and to hospital discharge
Procedural/In-hospital Evaluations
Time Frame: Discharge
Time to hospital discharge
Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endologix

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Holden, MD, Auckland City Hospital
  • Principal Investigator: Renato Mertens, MD, Hospital Universidad Catolica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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