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

Completed · Not applicable

Conditions studied: Aortic Aneurysm, Abdominal

In brief

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.

Key facts

Study ID

NCT00816062

Run by

Medtronic Cardiovascular

People needed

94

Starts

2008-12-01

Expected to finish

2015-07-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC Univerisity Hospital — Los Angeles, California, United States
• Palo Alto VAMC — Palo Alto, California, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• St. John's Medical Research Institute — Springfield, Missouri, United States
• Barnes Jewish — St Louis, Missouri, United States
• East Carolina University — Greenville, North Carolina, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Pinnacle Health Network — Harrisburg, Pennsylvania, United States
• Sanford USD Medical Center — Sioux Falls, South Dakota, United States
• North Central Heart Institute — Sioux Falls, South Dakota, United States
• St. Mary's Medical Center — Knoxville, Tennessee, United States
• Vanderbilt Vascular Surgery — Nashville, Tennessee, United States
• Wilford Hall Medical Center — Lackland Air Force Base, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Charleston Area Medical Center — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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