Thoracic Aortic AneurysmNCT00413231
Valor II: The Valiant Thoracic Stent Graft System Clinical Study
A study testing Valiant Thoracic Stent Graft System in people with Thoracic Aortic Aneurysm, run by Medtronic Cardiovascular at 26 sites in United States.
Trial summary
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thoracic Aortic Aneurysm
- What is being tested?
- Valiant Thoracic Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 26 sitesUnited States
- Study dates
- Dec 2006to Oct 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for enrollment, a subject must meet all of the following inclusion criteria:
- Subject is between the age of 18 and 85.
- Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk [categories 0, 1, and 2] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System
- If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure.
- Subject has a DTA that is:
- A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta;
Show all 16Show fewer
- AND/OR
- Saccular aneurysm (penetrating atherosclerotic ulcer)
- Subject's anatomy must meet all of the following anatomical criteria:
- Subject's TAA must be ≥ 20 mm distal to the origin of the left common carotid artery and must be ≥ 20 mm proximal to the celiac artery;
- Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm;
- Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length.
- Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within four (4) months prior to the implant procedure.
- Subject is able and willing to comply with the protocol and undergo follow-up requirements.
- Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
- Subject has patent iliac or femoral arteries or can tolerate a vascular conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate size device chosen for treatment.
Who cannot join
- To be eligible for enrollment, a subject cannot meet any of the following exclusion criteria:
- Planned placement of the COVERED portion of the stent graft requires implant to occur in zones 0 or 1.
- Subject has a thoracic aneurysm with a contained rupture.
- Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
- Subject has a mycotic aneurysm or is suspected of having systemic infection.
- Subject has received a previous stent or stent graft or previous surgical repair in the DTA.
Show all 15Show fewer
- Subject requires treatment of an infra-renal aneurysm at the time of implant.
- Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- Subject has had or plans to have a major surgical procedure within 30 days before or after the Valiant Stent Graft procedure. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure).
- Subject has had an MI or cerebral vascular accident (CVA) within 3 months.
- Subject is currently participating in an investigational drug or device clinical trial.
- Subject has a known allergy or intolerance to the device components.
- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
- Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device.
- Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude him or her from receiving this treatment and the procedures and evaluations pre- and post-treatment, or a limited life expectancy of less than 1 year.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Albany Medical Center
Albany, New York, 12208
Emory University Hospital
Atlanta, Georgia, 30322
Union Memorial
Baltimore, Maryland, 21218
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Florida
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06106
Baylor College of Medicine
Houston, Texas, 77030
St. Luke's Episcopal Hospital - Houston
Houston, Texas, 77030
University of Southern California - Healthcare Consultation Center
Los Angeles, California, 90033
Loyola University Medical Center
Maywood, Illinois, 60153
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Advance Vascular Associates (Morristown Memorial Hospital)
Morristown, New Jersey, 07960
New York University Medical Center
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Shadyside Hospital - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Minneapolis Vascular Physicians
Plymouth, Minnesota, 55441
William Beaumont Hospital
Royal Oak, Michigan, 48073
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: The Valiant Thoracic Stent Graft System. The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair.
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
Read the detailed description
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.
- Conditions
- Thoracic Aortic Aneurysm
- Being tested
- Valiant Thoracic Stent Graft System
- Keywords
- Thoracic Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft, Thoracic Aortic Aneurysm, Endovascular procedure, Descending Thoracic Aneurysm, Valiant Stent Graft System
- 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.
Valiant Thoracic Stent Graft SystemDevice
Also called Valiant device; Valiant stent graft.
Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
| Study group | Role | What they receive |
|---|---|---|
| Valiant Thoracic Stent Graft System | Experimental | 160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.
There were no other arms for this study. Receives: Device: Valiant Thoracic Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.
Measured: 0 through 1825 days post treatment
Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b.
Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device.
Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak).
Measured: At 12-month post procedure
Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated.
>
> Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks.
Measured: Within 12-months post treatment
Secondary outcomes (24)
Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.
Measured: At implant
Percentage of Participants That Experienced Perioperative Mortality
Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.
Measured: Within 30 days post treatment
Percentage of Participants That Experienced Paraplegia
Percentage of subjects that experienced paraplegia within 30 days post treatment
Measured: Within 30 days post treatment
Percentage of Participants That Experienced Paraparesis
Percentage of subjects that experienced paraparesis within 30 days post treatment
Measured: Within 30 days post treatment
Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment
Measured: Within 30 days post treatment
Percentage of Participants That Experienced One or More Major Adverse Events
Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device
Measured: Within 30 days post treatment
Percentage of Participants That Experienced Aneurysm-related Mortality
Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment
Measured: Within 12 months post treatment
Percentage of Participants That Experience Aneurysm Rupture
Percentage of subjects that experience aneurysm rupture within 12 months post treatment
Measured: Within 12 months post treatment
Percentage of Participants That Experienced Conversion to Open Surgical Repair
Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment
Measured: Within 12 months post treatment
Percentage of Participants That Experienced Endoleak(s)
Percentage of subjects that experienced endoleak(s) of any type at 12 months
Measured: At 12 months
Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months
Measured: Between 30 days and 12 months
Percentage of Participants That Experienced Stent Graft Migration
Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.
Measured: Within 12 months post treatment
Percentage of Participants That Experience Loss of Stent Graft Patency
Percentage of subjects that experience loss of stent graft patency within 12 months post treatment
Measured: Within 12 months post treatment
Percentage of Participants That Experienced One or More Major Adverse Events
Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment
Measured: Within 12 months post treatment
Percentage of Participants That Died (All-cause Mortality)
Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Aneurysm-related Mortality
Percentage of subjects that experienced aneurysm-related within five years post implant
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Aneurysm Ruptures
Percentage of subjects that experienced aneurysm ruptures within five years post implant
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Conversions to Open Surgical Repair
Percentage of subjects that experienced conversions to open surgical repair within five years post implant
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Type I Endoleaks
Percentage of subjects that experienced type I endoleaks within five years post implant
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Type III Endoleaks
Percentage of subjects that experienced type III endoleaks within five years post implant
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Type IV Endoleaks
Percentage of subjects that experienced type IV endoleaks within five years post implant
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Secondary Endovascular Procedures
Percentage of subjects that experienced secondary endovascular procedures within five years post implant
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites
Measured: 0 through 1825 days post treatment
Percentage of Participants That Experienced Loss of Stent Graft Patency
Percentage of subjects that experienced loss of stent graft patency within five years post implant
Measured: 0 through 1825 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2010
- Study completionOct 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Aortic AneurysmStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Fairman, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413231
- Sponsor's protocol ID
- Investigational Plan #078
- Status last verified
- Oct 2021
- First submitted
- 15 Dec 2006
- Last updated
- 3 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Conrad MF, Tuchek J, Freezor R, Bavaria J, White R, Fairman R. Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft. J Vasc Surg. 2017 Aug;66(2):335-342. doi: 10.1016/j.jvs.2016.12.136. Epub 2017 Mar 30.
PubMed 28366302
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Valiant Thoracic Stent Graft System. The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair.
- ClinicalTrials.gov ID
- NCT00413231
- Acronym / sponsor ID
- Investigational Plan #078
- Conditions
- Thoracic Aortic Aneurysm
- Keywords
- Thoracic Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft, Thoracic Aortic Aneurysm, Endovascular procedure, Descending Thoracic Aneurysm, Valiant Stent Graft System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Posted 5 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
Detailed description
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valiant Thoracic Stent Graft System | Experimental | Device: Valiant Thoracic Stent Graft System160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- To be eligible for enrollment, a subject must meet all of the following inclusion criteria:
- Subject is between the age of 18 and 85.
- Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk [categories 0, 1, and 2] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System
- If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure.
- Subject has a DTA that is:
Key exclusion criteria (15 listed)
- To be eligible for enrollment, a subject cannot meet any of the following exclusion criteria:
- Planned placement of the COVERED portion of the stent graft requires implant to occur in zones 0 or 1.
- Subject has a thoracic aneurysm with a contained rupture.
- Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
- Subject has a mycotic aneurysm or is suspected of having systemic infection.
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 |
|---|---|---|
| Valiant Thoracic Stent Graft SystemAlso: Valiant device; Valiant stent graft.Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm). | Device | Valiant Thoracic Stent Graft System |
Primary outcome
Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Time frame: 0 through 1825 days post treatment
Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.
Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
Time frame: At 12-month post procedure
Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak).
Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
Time frame: Within 12-months post treatment
The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. > > Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks.
24 secondary outcomes
Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
Time frame: At implant
Percentage of Participants That Experienced Perioperative Mortality
Time frame: Within 30 days post treatment
Percentage of Participants That Experienced Paraplegia
Time frame: Within 30 days post treatment
Percentage of Participants That Experienced Paraparesis
Time frame: Within 30 days post treatment
Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
Time frame: Within 30 days post treatment
Percentage of Participants That Experienced One or More Major Adverse Events
Time frame: Within 30 days post treatment
Percentage of Participants That Experienced Aneurysm-related Mortality
Time frame: Within 12 months post treatment
Percentage of Participants That Experience Aneurysm Rupture
Time frame: Within 12 months post treatment
Percentage of Participants That Experienced Conversion to Open Surgical Repair
Time frame: Within 12 months post treatment
Percentage of Participants That Experienced Endoleak(s)
Time frame: At 12 months
Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
Time frame: Between 30 days and 12 months
Percentage of Participants That Experienced Stent Graft Migration
Time frame: Within 12 months post treatment
Percentage of Participants That Experience Loss of Stent Graft Patency
Time frame: Within 12 months post treatment
Percentage of Participants That Experienced One or More Major Adverse Events
Time frame: Within 12 months post treatment
Percentage of Participants That Died (All-cause Mortality)
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Aneurysm-related Mortality
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Aneurysm Ruptures
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Conversions to Open Surgical Repair
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Type I Endoleaks
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Type III Endoleaks
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Type IV Endoleaks
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Secondary Endovascular Procedures
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
Time frame: 0 through 1825 days post treatment
Percentage of Participants That Experienced Loss of Stent Graft Patency
Time frame: 0 through 1825 days post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28366302Conrad MF, Tuchek J, Freezor R, Bavaria J, White R, Fairman R. Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft. J Vasc Surg. 2017 Aug;66(2):335-342. doi: 10.1016/j.jvs.2016.12.136. Epub 2017 Mar 30.
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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.
Ronald Fairman, MD principal investigator
University of Pennsylvania
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valiant Thoracic Stent Graft System in people with Thoracic Aortic Aneurysm, run by Medtronic Cardiovascular at 26 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 16 inclusion and 15 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 3 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 26 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 5 Apr 2012). 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?
Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) (time frame: 0 through 1825 days post treatment). The study lists 3 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 NCT00413231, which also lists 1 linked publication.
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 3 Nov 2021.