AMDS for Aortic Dissection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Aortic Dissection+1 More
AMDS - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a new medical device is safe and effective for treating a certain type of heart problem.

Eligible Conditions
  • Aortic Dissection
  • Dissection, Aortic Acute

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: At 1 year

At 1 year
Primary Endpoint
Primary Endpoint to Assess Change in Maximal True Lumen (TL) diameter
Through 30 days
Primary Endpoint to Assess Incidence of Major Adverse Events

Trial Safety

Trial Design

1 Treatment Group

Acute DeBakey Type I Dissection
1 of 1
Experimental Treatment

93 Total Participants · 1 Treatment Group

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

Acute DeBakey Type I Dissection
Device
Experimental Group · 1 Intervention: AMDS · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 year

Who is running the clinical trial?

CryoLife, Inc.Lead Sponsor
17 Previous Clinical Trials
2,201 Total Patients Enrolled
Artivion Inc.Lead Sponsor
5 Previous Clinical Trials
1,471 Total Patients Enrolled
1 Trials studying Aortic Dissection
40 Patients Enrolled for Aortic Dissection
Syneos HealthOTHER
155 Previous Clinical Trials
68,848 Total Patients Enrolled
Wilson Szeto, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
150 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 or older or 80 years of age or older at time of surgery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 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.