An interventional study of Valiant PS-IDE Stent Graft in Dissection of Thoracic Aorta, sponsored by Baylor Research Institute. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Baylor Research Institute · Not applicable, Interventional, and Treatment
The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending thoracic aortic pathologies including type A aortic dissection, who are suitable for endovascular repair with the Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System (or the Valiant PS-IDE Stent Graft).
The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending aortic pathologies including type A aortic dissection, retrograde type A aortic dissection, who are suitable for endovascular repair with the Valiant PS-IDE Stent Graft device. The investigators propose to study patients with Dissections affecting the aorta between the Sinus of Valsalva and the innominate artery orifice (with no involvement of aortic valve). In these patients, the ascending aorta will be repaired using the stent graft. For patients with type A aortic dissection, the investigators expect to reroute the blood to the true lumen by covering the proximal tear. In patients with retrograde type A aortic dissection, there might or might not be additional tears in the ascending aorta. If they are tears in ascending aorta, these dissections behave similarly like a type A aortic dissection, in which all the tears in the ascending aorta need to be covered. If the proximal tear is only in the descending thoracic aorta, these patients will require coverage in the ascending aorta with the stent graft along with coverage of proximal tear in the descending thoracic aorta using Valiant stent graft.
Patients will be selected from a high-risk surgical cohort. The total number of enrolled subjects is planned to be 20.
30 studies on the registry are indexed under Dissection, Thoracic Aorta; 10 are open to participants now.
This study's enrollment of 1 is below the median of 87 across 13 interventional studies indexed under Dissection, Thoracic Aorta.
Browse Dissection, Thoracic Aorta studies →Baylor Research Institute is the lead sponsor of 223 studies on the registry; 48 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
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In order to qualify for this physician-sponsored Device Exemption, the patients would have to meet the entire entry criteria listed below, sign a consent approved by the FDA and IRB, and agrees to follow-up according to the study protocol.
Patient must have a type A thoracic aortic dissection, retrograde type A thoracic aortic dissection of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered a candidate for endovascular repair;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair
Device: Valiant PS-IDE Stent Graft
Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System
Number of Participants With Freedom From Early Death
Number of participants with freedom from early death at 30-days post-procedure
Time frame: 30 days
| Milestone | Type A Dissection |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Number of participants with freedom from early death at 30-days post-procedure
| Participants | Type A Dissection |
|---|---|
| Number of Participants With Freedom From Early Death | 1 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Type A Dissection | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) |
| Event | Type A Dissection |
|---|---|
| Type 1B endoleakSurgical and medical procedures | 1/1 |
| Age, Categorical(Participants) | Type A Dissection |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Type A Dissection |
|---|---|
| Female | 1 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Type A Dissection |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Type A Dissection |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Type A Dissection |
|---|---|
| United States | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2018 to primary completion in Oct 2021, 34 months.
Results were first posted in Mar 2026, 4 years 4 months after primary completion.
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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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