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

Covidien

Status

Completed

Conditions

Aortic Aneurysm, Abdominal

Treatments

Device: Talent Abdominal Stent Graft

Study type

Interventional

Funder types

Industry

Identifiers

NCT00816062

P070027/S002

Details and patient eligibility

About

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.

Full 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.

Enrollment

94 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.