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

December 29, 2008
July 17, 2014
December 2008
June 2015   (final data collection date for primary outcome measure)
Aneurysm-related Mortality (ARM) [ Time Frame: 5 year KM ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00816062 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
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.

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.

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm, Abdominal
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.
Experimental: Treatment
Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.
Intervention: Device: Talent Abdominal Stent Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
94
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816062
P070027/S002
No
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Luis Sanchez, MD Washington University School of Medicine
Medtronic Endovascular
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP