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

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Device: Talent Abdominal Stent Graft

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Univerisity Hospital
    • Palo Alto, California, United States, 94304
      • Palo Alto VAMC
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish
    • Springfield, Missouri, United States, 65810
      • St. John's Medical Research Institute
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Harrisburg, Pennsylvania, United States, 17110
      • Pinnacle Health Network
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford USD Medical Center
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • St. Mary's Medical Center
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Vascular Surgery
  • Texas
    • Lackland Air Force Base, Texas, United States, 78236
      • Wilford Hall Medical Center
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • West Virginia
    • Charleston, West Virginia, United States, 23504
      • Charleston Area Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular

Publications and helpful links

Helpful Links

• Further information on the Talent Stent Graft

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: December 29, 2008
• First Submitted That Met QC Criteria: December 30, 2008
• First Posted (ESTIMATE): December 31, 2008

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Aneurysm; Medtronic; Aortic Aneurysm; Abdominal Aortic Aneurysm; Talent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: P070027/S002