Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

NCT01348828 | Completed Results DMC

• 1 other identifier: CP-0003
• Study Type: interventional
• Target: 49
• Locations: 6 countries
• Sites: 8

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; Fenestrated; Renal Stent; Juxtarenal; Pararenal; Endologix; Renal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Feasibility/Effectiveness

  1 Year

• Procedural/In-hospital Evaluations

  Procedurally and to hospital discharge

• Mortality

  Procedurally and to 5 Years

• Major Adverse Events

  >30 Days to 5 Years

• Number of Participants With Renal Dysfunction

  30 Days, 6 Months and Years 1 to 5

Study Arms (1)

Single Arm

OTHER

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)

Interventions

Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System) DEVICE

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

Also known as: Ventana, Xpand

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endologix: lead

Study Sites (8)

UCLA

Los Angeles, California, 90024, United States

Location

University of Indiana

Indianapolis, Indiana, 46202, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital Universidad Catolica

Santiago, Chile

Location

Bureau de Recherche Clinique

Créteil, 94000, France

Location

Rijnstate Hospital

Arnhem, 6800, Netherlands

Location

Auckland City Hospital

Auckland, 1032, New Zealand

Location

St. George's Vascular Institute

London, SW17 0RE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22545881 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Sripad Bellary, Director Clinical Affairs
• Organization: Endologix

sbellary@endologix.com

9257011628

Study Officials

• Daniel Clair, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Andrew Holden, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Renato Mertens, MD

  Hospital Universidad Catolica

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 5, 2011
• Study Start: October 19, 2011
• Primary Completion: May 1, 2013
• Study Completion: March 20, 2018
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-09

Locations

NL (1); FR (1); CL (1); NZ (1); GB (1); US (3)