MedDataX Logo

Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

NCT ID: NCT01348828

Last Updated: 2021-10-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-19

Study Completion Date

2018-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Aortic Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)

Intervention Type DEVICE

Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)

Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ventana Xpand

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Endologix

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Clair, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Andrew Holden, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Renato Mertens, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universidad Catolica

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCLA

Los Angeles, California, United States

Site Status

University of Indiana

Indianapolis, Indiana, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Hospital Universidad Catolica

Santiago, , Chile

Site Status

Bureau de Recherche Clinique

Créteil, , France

Site Status

Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

St. George's Vascular Institute

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Chile France Netherlands New Zealand United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 22545881 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP-0003

Identifier Type: -

Identifier Source: org_study_id