Thoracic Aortic AneurysmsPhase 2/3VALORNCT00604799

VALOR: The Talent Thoracic Stent Graft System Clinical Study

A Phase 2/3 study testing Talent Thoracic Stent Graft in people with Thoracic Aortic Aneurysms, run by Medtronic Cardiovascular at 1 site 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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Thoracic Aortic Aneurysms
What is being tested?: Talent Thoracic Stent Graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 379 participants
Where: 1 siteUnited States
Study dates: Jul 2003to Jun 2011
Phase: Phase 2/3
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult, Older adult

Talent Captivia Inclusion Criteria

Patient is at least 18 years of age.
Patient is a surgical or non-surgical candidate
Patient has a:
Fusiform focal TAA AND / OR
Focal saccular TAA or penetrating atherosclerotic ulcer.
Subject's anatomy must meet all of the following anatomical criteria:
iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
non-aneurysmal aortic diameter in the range of 18-42mm; and
non-aneurysmal aortic proximal and distal neck lengths =/>20mm
Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CTA) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram (MRA) obtained within the previous three (3) months prior to the implant procedure.
Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.

Talent Captivia Exclusion Criteria

Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1
Pregnant female
Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).
Patient has a mycotic aneurysm or is suspected of having systemic infection.
Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.
The patient has known allergy or intolerance to the device components.
The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
The patient has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or limited life expectancy of less than 6 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms

A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.

Conditions: Thoracic Aortic Aneurysms
Being tested: Talent Thoracic Stent Graft
Medical subject headings: Aortic Aneurysm, Thoracic

What participants receive

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

Talent Thoracic Stent GraftDevice
TEVAR

Study groups in NCT00604799
Study group	Role	What they receive
Test (Enrollment Completed)	Active comparator	Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, \& 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery \& 20 mm proximal to the origin of the celiac artery. Receives: Device: Talent Thoracic Stent Graft
Registry (Enrollment Completed)	Other	Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria. Receives: Device: Talent Thoracic Stent Graft
High Risk (Enrollment Completed)	Other	Patients that meet one or more of the following: * High Risk (SVS 3) * Non-surgical candidates not associated with SVS scoring * Traumatic thoracic injuries Receives: Device: Talent Thoracic Stent Graft
Talent Captivia (Recruiting)	Other	Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria. Receives: Device: Talent Thoracic Stent Graft

What is being measured

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

Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.
Measured: 12 months
Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up.
Measured: 12 months

Timeline

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

Jul 2003Jun 2011

First posted30 Jan 2008 (estimated)
Study startJul 2003
Primary completionJun 2006
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Thoracic Aortic AneurysmsStudies 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 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 379 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00604799
Sponsor's protocol ID: Investigational Plan #031
Acronym: VALOR
Status last verified: Oct 2021
First submitted: 21 Dec 2007
Last updated: 2 Nov 2021
Results posted: No
Data monitoring committee: Yes

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?

See locations

Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

All Thoracic Aortic Aneurysms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms
ClinicalTrials.gov ID: NCT00604799
Acronym / sponsor ID: VALOR / Investigational Plan #031
Conditions: Thoracic Aortic Aneurysms
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 379 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: Jul 2003
Primary completion: Jun 2006 (actual)
Study completion: Jun 2011 (actual)
First posted: 30 Jan 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Test (Enrollment Completed)	Active comparator	Device: Talent Thoracic Stent GraftPatients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, \& 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery \& 20 mm proximal to the origin of the celiac artery.
Registry (Enrollment Completed)	Other	Device: Talent Thoracic Stent GraftSurgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.
High Risk (Enrollment Completed)	Other	Device: Talent Thoracic Stent GraftPatients that meet one or more of the following: * High Risk (SVS 3) * Non-surgical candidates not associated with SVS scoring * Traumatic thoracic injuries
Talent Captivia (Recruiting)	Other	Device: Talent Thoracic Stent GraftPatients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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 Thoracic Stent GraftTEVAR	Device	High Risk (Enrollment Completed), Registry (Enrollment Completed), Talent Captivia (Recruiting), Test (Enrollment Completed)

Primary outcome

Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.
Time frame: 12 months
Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up.
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.

Related trials for Thoracic Aortic Aneurysms

Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

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.

Mark Kaye, MD principal investigator

Physician's Regional Medical Center

Phillip Allmendinger, MD principal investigator

Hartford Hospital

Mark Bates, MD principal investigator

CAMC Health System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Talent Thoracic Stent Graft in people with Thoracic Aortic Aneurysms, run by Medtronic Cardiovascular at 1 site 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?

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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604799.

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 2 Nov 2021.