Stent Graft for Aortic Dissection
(PS-IDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the Valiant Stent Graft generally safe for humans?
How is the Valiant PS-IDE Stent Graft treatment different from other treatments for aortic dissection?
The Valiant PS-IDE Stent Graft is unique because it is an advanced version of previous stent grafts, designed specifically for endovascular repair (a minimally invasive procedure) of the thoracic aorta. It offers a new delivery system that may improve precision and reduce complications compared to older models.12345
What data supports the effectiveness of the Valiant PS-IDE Stent Graft treatment for aortic dissection?
Who Is on the Research Team?
William Brinkman, MD
Principal Investigator
Cardiac Surgery Specialists
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Endovascular repair of ascending aortic pathologies using the Valiant PS-IDE Stent Graft System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Valiant PS-IDE Stent Graft
Valiant PS-IDE Stent Graft is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor Research Institute
Lead Sponsor
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc