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

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Talent Abdominal Stent Graft
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring Aortic Aneurysm, Aneurysm, Abdominal Aortic Aneurysm, Talent, Medtronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC Univerisity Hospital
  • Palo Alto VAMC
  • Christiana Care Health Services
  • Washington Hospital Center
  • Mayo Clinic Jacksonville
  • Barnes Jewish
  • St. John's Medical Research Institute
  • East Carolina University
  • Forsyth Medical Center
  • Lehigh Valley Hospital
  • Pinnacle Health Network
  • Sanford USD Medical Center
  • North Central Heart Institute
  • St. Mary's Medical Center
  • Vanderbilt Vascular Surgery
  • Wilford Hall Medical Center
  • Inova Fairfax Hospital
  • Charleston Area Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2008
Last Updated
October 27, 2021
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT00816062
Brief Title
Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
Acronym
VITALITY
Official Title
Endovascular Repair Using the Talent™ Abdominal Stent Graft System in Abdominal Aortic Aneurysms (VITALITY)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal
Keywords
Aortic Aneurysm, Aneurysm, Abdominal Aortic Aneurysm, Talent, Medtronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.
Intervention Type
Device
Intervention Name(s)
Talent Abdominal Stent Graft
Intervention Description
The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.
Primary Outcome Measure Information:
Title
Freedom From Aneurysm-related Mortality (ARM)
Description
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.
Time Frame
5 year Kaplan Meier (KM)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Sanchez, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Univerisity Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Palo Alto VAMC
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Barnes Jewish
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. John's Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Pinnacle Health Network
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
North Central Heart Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
St. Mary's Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Vanderbilt Vascular Surgery
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
23504
Country
United States

12. IPD Sharing Statement

Links:
URL
http://talentstentgraft.com
Description
Further information on the Talent Stent Graft

Learn more about this trial

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

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