Aortic Aneurysm, AbdominalVITALITYNCT00816062

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

A study testing Talent Abdominal Stent Graft in people with Aortic Aneurysm, Abdominal, run by Medtronic Cardiovascular at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Aneurysm, Abdominal
What is being tested?: Talent Abdominal Stent Graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 18 sitesUnited States
Study dates: Dec 2008to Jul 2015
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 22Show fewer

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.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Charleston Area Medical Center
Charleston, West Virginia, 23504
Inova Fairfax Hospital
Falls Church, Virginia, 22042
East Carolina University
Greenville, North Carolina, 27834
Pinnacle Health Network
Harrisburg, Pennsylvania, 17110
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
St. Mary's Medical Center
Knoxville, Tennessee, 37923
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
USC Univerisity Hospital
Los Angeles, California, 90033
Vanderbilt Vascular Surgery
Nashville, Tennessee, 37232
Christiana Care Health Services
Newark, Delaware, 19713
Palo Alto VAMC
Palo Alto, California, 94304
Sanford USD Medical Center
Sioux Falls, South Dakota, 57104
North Central Heart Institute
Sioux Falls, South Dakota, 57108
St. John's Medical Research Institute
Springfield, Missouri, 65810
Barnes Jewish
St Louis, Missouri, 63110
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Forsyth Medical Center
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Endovascular Repair Using the Talent™ Abdominal Stent Graft System in Abdominal Aortic Aneurysms (VITALITY)

Read the 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
Being tested: Talent Abdominal Stent Graft
Keywords: Aortic Aneurysm, Aneurysm, Abdominal Aortic Aneurysm, Talent, Medtronic
Medical subject headings: Aortic Aneurysm, Abdominal, Aortic Aneurysm, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00816062
Study group	Role	What they receive
Treatment	Experimental	Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU. Receives: Device: Talent Abdominal Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 year Kaplan Meier (KM)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Jul 2015

First posted31 Dec 2008 (estimated)
Study startDec 2008
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00816062
Sponsor's protocol ID: P070027/S002
Acronym: VITALITY
Status last verified: Oct 2021
First submitted: 29 Dec 2008
Last updated: 29 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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