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

NCT00816062 | Completed Results

• 1 other identifier: P070027/S002
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 18

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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Freedom From Aneurysm-related Mortality (ARM)

  ARM is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness.

  5 year Kaplan Meier (KM)

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: Talent Abdominal Stent Graft

Interventions

Talent Abdominal Stent Graft DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (18)

USC Univerisity Hospital

Los Angeles, California, 90033, United States

Location

Palo Alto VAMC

Palo Alto, California, 94304, United States

Location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

St. John's Medical Research Institute

Springfield, Missouri, 65810, United States

Location

Barnes Jewish

St Louis, Missouri, 63110, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Pinnacle Health Network

Harrisburg, Pennsylvania, 17110, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57104, United States

Location

North Central Heart Institute

Sioux Falls, South Dakota, 57108, United States

Location

St. Mary's Medical Center

Knoxville, Tennessee, 37923, United States

Location

Vanderbilt Vascular Surgery

Nashville, Tennessee, 37232, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 23504, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Rianna Rapson
• Organization: Medtronic

rianna.k.rapson@medtronic.com

7635262170

Study Officials

• Luis Sanchez, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 31, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 29, 2021
• Results First Posted: January 23, 2018

Record last verified: 2021-10

Locations

US (18)