Status:
COMPLETED
Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Aortic Aneurysm, Abdominal
Eligibility:
All Genders
18+ years
Phase:
NA
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 envir...
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 supra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00816062
Start Date
December 1 2008
End Date
July 1 2015
Last Update
October 29 2021
Active Locations (18)
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1
USC Univerisity Hospital
Los Angeles, California, United States, 90033
2
Palo Alto VAMC
Palo Alto, California, United States, 94304
3
Christiana Care Health Services
Newark, Delaware, United States, 19713
4
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010