Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

NCT01491945 | Completed Results DMC FDA Device

• 1 other identifier: CP-0004
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 22

Brief Summary

The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysm; Renal stent; Juxtarenal; Pararenal; Endovascular

Outcome Measures

Primary Outcomes (2)

• Safety- Number of Major Adverse Events at 30 Days

  Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc

  30 Days

• Effectiveness

  1. Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. 2. Procedural Technical Success is defined as a subject with successful implant. 3. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 4. 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). 5. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).

  1 Year

Secondary Outcomes (11)

• Safety- Number of Major Adverse Events > 30 Days to 5 Years

  >30 Days to 5 Years

• Renal Dysfunction

  Discharge to 5 Years

• Endoleaks

  30 Days to 5 Years

• Clinical Utility Outcomes

  At the time of the procedure

• Time in ICU

  In-Hospital

Study Arms (1)

Ventana Fenestrated Stent Graft System

EXPERIMENTAL

Ventana Fenestrated Stent Graft System

Device: Ventana Fenestrated Stent Graft System

Interventions

Ventana Fenestrated Stent Graft System DEVICE

The Ventana Fenestrated Stent Graft System consists of the following: bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts

Ventana Fenestrated Stent Graft System

Eligibility Criteria

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

You may qualify if:

• Male or female at least 18 years old;
• Informed consent understood and signed and patient agrees to all follow-up visits;
• Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (\>0.5cm in six months), or \>50% larger than the normal aortic diameter
• Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:
• 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 ≥70mm
• SMA to aortoiliac bifurcation length ≥90mm;
• Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac;
• Angle ≤60° (clock face) between the SMA and CA
• Renal arteries both distal to the SMA by ≤35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length ≥15 mm; ability to preserve at least one hypogastric artery; diameter ≥10 mm and ≤23 mm; angle ≤90° to the aortic bifurcation.
• The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm.
• Aortic diameter at the most caudal renal artery of 18 to 36mm

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 or myocardial infarction;
• Prior renal transplant;
• Length of either renal artery to be stented \<13mm;

Sponsors & Collaborators

• Endologix: lead

Study Sites (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35429, United States

Location

Arizona Heart Institute

Phoenix, Arizona, 85016, United States

Location

John Muir Medical Center Concord, CA

Concord, California, 94520, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

VA Gainesville

Gainesville, Florida, 32608, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Baptist East Hospital

Louisville, Kentucky, 40207, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

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 of Clinical Affairs
• Organization: Endologix

sbellary@endologix.com

9257011628

Study Officials

• Daniel G Clair, MD

  The Cleveland Clinic

  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: October 20, 2011
• First Posted: December 14, 2011
• Study Start: March 3, 2013
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2018
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-09

Locations

US (22)