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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00816062
First received: December 29, 2008
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Aortic Aneurysm, Abdominal
Device: Talent Abdominal Stent Graft
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Repair Using the Talent™ Abdominal Stent Graft System in Abdominal Aortic Aneurysms (VITALITY)

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Aneurysm-related Mortality (ARM) [ Time Frame: 5 year KM ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 94
Study Start Date: December 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

The Talent Abdominal Stent Graft System is a next-generation modular system for endovascular repair of 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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816062

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

Additional Information:
No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00816062     History of Changes
Other Study ID Numbers: P070027/S002
Study First Received: December 29, 2008
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Endovascular:
Aortic Aneurysm
Aneurysm
Abdominal Aortic Aneurysm
Talent
Medtronic

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 28, 2014