Clinical trial NCT00816062: Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
Official title: Endovascular Repair Using the Talent™ Abdominal Stent Graft System in Abdominal Aortic Aneurysms (VITALITY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: Aortic Aneurysm
Aneurysm
Abdominal Aortic Aneurysm
Talent
Medtronic
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2008-12-31
Enrollment: 94
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 study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.

Detailed description: The Talent Abdominal Stent Graft System is a next-generation modular system for endovascular repair of Abdominal Aortic Aneurysm (AAA). The system was designed with the following enhancements: a suprarenal wire frame to provide migration resistance, and improved flexibility designed to treat difficult anatomies.

Medtronic Vascular submitted a Pre-Market Application (PMA) to the Food and Drug Administration (FDA) on October 17, 2007, and received market approval for the Talent Abdominal Stent Graft System on April 15th, 2008. As a condition of approval, the FDA has requested a post-approval study. Medtronic has therefore designed a post-approval study, in collaboration with FDA, to document the performance of the Talent Abdominal Stent Graft System under market conditions.

Eligibility criteria: Inclusion Criteria:

* Subject must have an abdominal aortic aneurysm, with or without iliac involvement.
* Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
* A proximal aortic neck length of ≥ 10mm;
* Proximal aortic neck angulation ≤ 60°;
* Distal iliac artery fixation length of ≥ 15mm;
* An aortic neck diameter of 18-32mm and iliac artery diameters of 8-22mm; and
* Vessel morphology suitable for endovascular repair.

Exclusion Criteria:

* Are less than 18 years of age
* Are pregnant or lactating
* Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and/or superior mesenteric artery
* Have aneurysmal involvement or occlusion (surgically performed or naturally occurring) of the bilateral internal iliac arteries
* Have vessels and/or aneurysm dimensions that cannot accommodate the Talent Abdominal Stent Graft as per the indications in Section 3.
* Have no distal vascular bed (one vessel lower extremity run-off required)
* Have contraindications for use of contrast medium or anticoagulation drugs
* Have an uncorrectable coagulopathy
* Have an SVS/AAVS score greater than 2
* Have a mycotic aneurysm
* Have circumferential mural thrombus in the proximal aortic neck
* Have had a recent (within 3 months) myocardial infarction (MI), cerebral vascular accident (CVA), or major surgical intervention
* Have traumatic aortic injury
* Have leaking, pending rupture or ruptured aneurysms
* Have pseudoaneurysms resulting from previous graft placement
* Require a revision to previously placed endovascular stent grafts.
* Have genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos' Syndromes)
* Have concomitant thoracic aortic or thoracoabdominal aneurysms
* Are patients with active systemic infections
* Are patients who have a condition that threatens to infect the graft.
* Are patients with sensitivities or allergies to the device materials.
* Have access vessels (as determined by treating physician) that preclude safe insertion of the delivery system. NOTE: Iliac conduits may be used to ensure the safe insertion of the delivery system.

Primary outcomes:
measure: Freedom From Aneurysm-related Mortality (ARM)
timeFrame: 5 year Kaplan Meier (KM)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Univerisity Hospital
state: California
city: Palo Alto
country: United States
facility: Palo Alto VAMC
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Saint Louis
country: United States
facility: Barnes Jewish
state: Missouri
city: Springfield
country: United States
facility: St. John's Medical Research Institute
state: Missouri
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Network
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Knoxville
country: United States
facility: St. Mary's Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Vascular Surgery
state: Tennessee
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
affiliation: Washington University School of Medicine
name: Luis Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References: