AMDS for Aortic Dissection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Aortic Dissection+3 More
AMDS - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial investigates a new treatment for aortic dissections and intramural hematomas. The goal is to see if it is effective and safe.

Eligible Conditions
  • Aortic Dissection
  • Hematoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Annually, through study completion, an average of 5 years

Year 5
AMDS related re-interventions after the dissection repair
Aortic arch branch vessel patency
Aortic injury associated with the implantation of the device
Assess need for stent removal
Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device
Successful reattachment of the intimal flap within the arch
Thrombosis of the false lumen within the confines of the device
Late (6 months)
Number of participants with device-related mortality
Number of participants with neurological complications (TIA, stroke)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

AMDS Implantation
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

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

AMDS Implantation
Device
Experimental Group · 1 Intervention: AMDS · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: annually, through study completion, an average of 5 years

Who is running the clinical trial?

Artivion Inc.Industry Sponsor
5 Previous Clinical Trials
1,524 Total Patients Enrolled
Ascyrus Medical LLC.Lead Sponsor
2 Previous Clinical Trials
107 Total Patients Enrolled
1 Trials studying Aortic Dissection
100 Patients Enrolled for Aortic Dissection
Jessica Forcillo, MDPrincipal InvestigatorCentre Hospitalier de I'Universite de Montreal
Philippe DemersPrincipal InvestigatorMontreal Heart Institute
Michael Moon, MDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
251 Total Patients Enrolled
Maral Ouzounian, MDPrincipal InvestigatorUniversity Health Network - Toronto General Hospital
Michael Chu, MDPrincipal InvestigatorLondon Health Science Center
1 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 13th, 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.