Zenith® Fenestrated+ Clinical Study

Cook Research Incorporated105 enrolled

Overview

The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. Up to 60 additional subjects may be enrolled in Continued Access phase of the study

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Aortic Aneurysm, Abdominal Juxtarenal Aortic Aneurysm Extent IV Thoracoabdominal Pararenal Aneurysm

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Include Criteria: 1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females 2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months 3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator Exclusion Criteria: 1. Age \< 18 years 2. Life expectancy \< 2 years 3. Pregnant, breast-feeding, or planning to become pregnant within 60 months 4. Inability or refusal to give informed consent by the patient or legally authorized representative 5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging 6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

Locations (33)

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

RECRUITING

UC San Diego

La Jolla, California, United States

RECRUITING

University of Southern California

Los Angeles, California, United States

RECRUITING

Stanford Hospitals and Clinics

Stanford, California, United States

Outcomes

Primary Outcomes

Composite measure of device technical success and procedural safety

Percent of patients with device technical success and freedom from procedural safety events in the following criteria: 1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and 2. Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke

Time frame: 30 days post procedure

Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention

Percent of patients meeting the following criteria: 1. Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and 2. Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)

Time frame: 12 months post procedure

Zenith® Fenestrated+ Clinical Study

Overview

Conditions

Interventions

Eligibility

Locations (33)

Outcomes

Primary Outcomes

Central Contacts