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

NCT ID: NCT00816062

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2015-07-31

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 environment.

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 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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

Aortic Aneurysm; Aneurysm; Abdominal Aortic Aneurysm; Talent; Medtronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.

Group Type: EXPERIMENTAL

Talent Abdominal Stent Graft

Intervention Type: DEVICE

The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.

Interventions

Talent Abdominal Stent Graft

The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Sanchez, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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

Countries

United States

Other Identifiers

P070027/S002

Identifier Type: -

Identifier Source: org_study_id