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.
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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
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
About this study
Official title: Endovascular Repair Using the Talent™ Abdominal Stent Graft System in Abdominal Aortic Aneurysms (VITALITY)
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Sanchez, MD, Principal investigator, Washington University School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Repair Using the Talent™ Abdominal Stent Graft System in Abdominal Aortic Aneurysms (VITALITY)
- ClinicalTrials.gov ID
- NCT00816062
- Acronym / sponsor ID
- VITALITY / P070027/S002
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Aortic Aneurysm, Aneurysm, Abdominal Aortic Aneurysm, Talent, Medtronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Talent Abdominal Stent GraftPatients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talent Abdominal Stent GraftThe Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. | Device | Treatment |
Primary outcome
Freedom From Aneurysm-related Mortality (ARM)
Time frame: 5 year Kaplan Meier (KM)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Sanchez, MD principal investigator
Washington University School of Medicine
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talent Abdominal Stent Graft in people with Aortic Aneurysm, Abdominal, run by Medtronic Cardiovascular at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Aneurysm-related Mortality (ARM) (time frame: 5 year Kaplan Meier (KM)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.