Valiant PS-IDE Stent Graft for Aortic Dissection

Baylor Scott & White The Heart Hospital, Plano, TX
Aortic DissectionValiant PS-IDE Stent Graft - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is to see if a new stent graft system is safe and effective for treating ascending thoracic aortic pathologies.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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TTI-101 400 mg/day
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Zenith® t-Branch
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Medtronic Valiant Thoracoabdominal Stent Graft System

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 30 days

30 days
Freedom from early death

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

2
TTI-101 400 mg/day
1
Zenith® t-Branch
1
Medtronic Valiant Thoracoabdominal Stent Graft System

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Type A Dissection
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Valiant PS-IDE Stent Graft · No Placebo Group · N/A

Type A Dissection
Device
Experimental Group · 1 Intervention: Valiant PS-IDE Stent Graft · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days

Who is running the clinical trial?

MedtronicIndustry Sponsor
585 Previous Clinical Trials
820,261 Total Patients Enrolled
3 Trials studying Aortic Dissection
449 Patients Enrolled for Aortic Dissection
Baylor Research InstituteLead Sponsor
191 Previous Clinical Trials
186,212 Total Patients Enrolled
William Brinkman, MDPrincipal InvestigatorCardiac Surgery Specialists
5 Previous Clinical Trials
2,397 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The areas where the graft will be placed should be at least 1 cm apart. The placement should not block important blood vessels or the heart valve. If there is a tear in the aortic root, it must be at least 1 cm away from the STJ (and within the above size criteria).
The location where the treatment will be done should not affect the blood flow to important blood vessels in the brain.
References

Frequently Asked Questions

Are any new participants accepted for this clinical experiment?

"Patient recruitment is currently live for this trial, the details of which were published on clinicaltrials.gov in December 2018 and last updated March 2022." - Anonymous Online Contributor

Unverified Answer

How many individuals have enlisted in this trial?

"Affirmative. Clinicaltrials.gov attests that this research project, first posted on December 15th 2018 and last updated March 7th 2022 is still recruiting participants. Specifically, they are seeking 20 individuals at a single location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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