Clinical trial NCT01491945: Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
Official title: Prospective, Multicenter, Single Arm Safety and Effectiveness Trial of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal aortic aneurysm
Renal stent
Juxtarenal
Pararenal
Endovascular
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Safety- Number of Major Adverse Events at 30 Days
timeFrame: 30 Days
measure: Effectiveness
timeFrame: 1 Year
Secondary outcomes:
measure: Safety- Number of Major Adverse Events > 30 Days to 5 Years
timeFrame: >30 Days to 5 Years
measure: Renal Dysfunction
timeFrame: Discharge to 5 Years
measure: Endoleaks
timeFrame: 30 Days to 5 Years
measure: Clinical Utility Outcomes
timeFrame: At the time of the procedure
measure: Time in ICU
timeFrame: In-Hospital
measure: Time to Hospital Discharge
timeFrame: Hospital Discharge (Post-Procedure)
measure: Device Patency
timeFrame: 30 Days to 5 Years
measure: Device Integrity
timeFrame: 30 Days to 5 Years
measure: Aneurysm Sac Morphology
timeFrame: 30 Days to 5 Years
measure: Aneurysm Sac Diameter
timeFrame: 30 Days to 5 Years
measure: Clinical Utility Outcomes
timeFrame: At the time of the procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Concord
country: United States
facility: John Muir Medical Center Concord, CA
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Gainesville
country: United States
facility: VA Gainesville
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Louisville
country: United States
facility: Baptist East Hospital
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: Daniel G Clair, MD
role: PRINCIPAL_INVESTIGATOR
References: