Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

NCT ID: NCT01491945

Last Updated: 2021-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-03
• Study Completion Date: 2018-08-01

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.

Detailed Description

Study Objectives The objective of protocol CP-0004 is to study the safety and effectiveness of the Endologix Fenestrated System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms.

Study Design This clinical study is a prospective, non-randomized, multicenter study. The first patient enrolled at each site is designated as a 'Roll-In' group patient. Subsequently, enrolled patients are designated as 'Trial' group patients for primary endpoint analysis.

Primary Endpoint The primary safety endpoint is defined as the incidence of Major Adverse Events‡ (MAEs) within 30 days. The primary study effectiveness endpoint is Treatment Success at 1-year. This is defined as procedural technical success and the absence of aneurysm rupture; conversion to open surgical 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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ventana Fenestrated Stent Graft System

Ventana Fenestrated Stent Graft System

Group Type: EXPERIMENTAL

Ventana Fenestrated Stent Graft System

Intervention Type: 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

Interventions

Ventana Fenestrated Stent Graft System

The Ventana Fenestrated Stent Graft System consists of the following:

bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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 or myocardial infarction;
• Prior renal transplant;
• Length of either renal artery to be stented <13mm;
• Significant occlusive disease of either renal artery (>70% stenosis);
• An essential accessory renal artery;
• Indispensable inferior mesenteric artery;
• 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 (female patient of childbearing potential only)
• Existing renal stent;
• Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel G Clair, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Heart Institute

Phoenix, Arizona, United States

John Muir Medical Center Concord, CA

Concord, California, United States

UCLA Medical Center

Los Angeles, California, United States

VA Gainesville

Gainesville, Florida, United States

Emory University

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

Baptist East Hospital

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Methodist Hospital

Houston, Texas, United States

Harborview Medical Center

Seattle, Washington, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CP-0004

Identifier Type: -

Identifier Source: org_study_id