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Stent Graft

Stent Graft for Aortic Dissection (PS-IDE Trial)

N/A
Recruiting
Led By William Brinkman, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have a type A thoracic aortic dissection 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
The proximal and distal landing zones for placement of graft should be at least 1 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

PS-IDE Trial Summary

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

Who is the study for?
This trial is for adults with a type A thoracic aortic dissection who need an alternative to traditional surgery. They must have specific measurements of their aorta, be high-risk surgical candidates (ASA score IV), and not pregnant or expected to live less than one year due to another condition.Check my eligibility
What is being tested?
The study tests the Valiant PS-IDE Stent Graft System in patients with ascending thoracic aortic pathologies. It aims to see if this endovascular repair method is feasible and safe for those who are unsuitable for conventional surgery.See study design
What are the potential side effects?
Potential side effects may include complications related to the stent graft placement such as infection, allergic reactions to materials, blockage of blood flow, or impact on heart valve function.

PS-IDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a type A thoracic aortic dissection suitable for endovascular repair.
Select...
The areas for my graft placement are at least 1 cm apart.
Select...
My aorta's width is between 28 mm and 44 mm at specific points.

PS-IDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from early death

PS-IDE Trial Design

1Treatment groups
Experimental Treatment
Group I: Type A DissectionExperimental Treatment1 Intervention
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,645 Total Patients Enrolled
3 Trials studying Aortic Dissection
449 Patients Enrolled for Aortic Dissection
Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,206 Total Patients Enrolled
William Brinkman, MDPrincipal InvestigatorCardiac Surgery Specialists
5 Previous Clinical Trials
2,397 Total Patients Enrolled

Media Library

Valiant PS-IDE Stent Graft (Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT03322033 — N/A
Aortic Dissection Research Study Groups: Type A Dissection
Aortic Dissection Clinical Trial 2023: Valiant PS-IDE Stent Graft Highlights & Side Effects. Trial Name: NCT03322033 — N/A
Valiant PS-IDE Stent Graft (Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03322033 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Feasibility of Endovascular Repair of Ascending Aortic Pathologies
2018. "Feasibility of Endovascular Repair of Ascending Aortic Pathologies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03322033.
~7 spots leftby Jan 2027
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