Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms

Aortic Aneurysm, Abdominal Clinical Trial

— VITALITY  

Official title:

Endovascular Repair Using the Talent™ Abdominal Stent Graft System in Abdominal Aortic Aneurysms (VITALITY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816062
• Other study ID #: P070027/S002
• Status: Completed
• Phase: N/A
• Start date: December 2008
• Est. completion date: July 2015

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Talent Abdominal Stent Graft
The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	East Carolina University	Greenville	North Carolina
United States	Pinnacle Health Network	Harrisburg	Pennsylvania
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	St. Mary's Medical Center	Knoxville	Tennessee
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	USC Univerisity Hospital	Los Angeles	California
United States	Vanderbilt Vascular Surgery	Nashville	Tennessee
United States	Christiana Care Health Services	Newark	Delaware
United States	Palo Alto VAMC	Palo Alto	California
United States	Barnes Jewish	Saint Louis	Missouri
United States	North Central Heart Institute	Sioux Falls	South Dakota
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	St. John's Medical Research Institute	Springfield	Missouri
United States	Washington Hospital Center	Washington	District of Columbia
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Aneurysm-related Mortality (ARM)	ARM is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness.	5 year Kaplan Meier (KM)

External Links

•   Further information on the Talent Stent Graft