Treatment for Aortic Aneurysm, Thoracic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Aortic Aneurysm, Thoracic+3 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a new device is safe and effective for treating aortic arch and descending thoracic aorta lesions.

Eligible Conditions
  • Aortic Aneurysm, Thoracic
  • Aorta

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: one year

12 Months
Proportion of Participants With Primary Endpoint Success for Zone 2
one year
Composite of technical success and adverse events for Zone 2 Subjects (Aneurysm Cohort)

Trial Safety

Trial Design

0 Treatment Group

246 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
81 Previous Clinical Trials
17,757 Total Patients Enrolled
10 Trials studying Aortic Aneurysm, Thoracic
1,161 Patients Enrolled for Aortic Aneurysm, Thoracic
Michael M Dake, MDPrincipal InvestigatorStanford University
Himanshu Patel, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Aortic Aneurysm, Thoracic
150 Patients Enrolled for Aortic Aneurysm, Thoracic

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
An individual must be at least 18 years old in order to sign an informed consent form.
The aorta must have a landing zone that is close to the heart.
The text is saying that in order for the target branch vessel landing zone to be appropriate, it must meet certain criteria.
For patients with an aneurysm or isolated lesion, they must have an appropriate distal aortic landing zone.
The text is saying that the thoracic aorta has some sort of pathology that requires surgery, and that this surgery will require the placement of a graft in the proximal portion of the aorta in Zone 0-2.
The subject is able to comply with the requirements of the protocol, including any follow-up required.
You have signed a written consent form.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.