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Aortic Stent Graft

AMDS for Aortic Dissection (DARTS I Trial)

Q: Is this clinical test being conducted in more than one hospital within the city limits?

This trial is currently recruiting at 5 different locations, these include University Health Network - Toronto General Hospital in Toronto, Montreal Heart Institute in Montréal, and London Health Sciences Center- University Hospital in London among others.

Q: For which patients is this experimental treatment being made available?

This research study is investigating aortic dissection and thus, participants must have this condition to be eligible. The age limit for potential subjects is 18-80 years old and the trial will enroll 40 individuals in total.

Q: Are the elderly eligible for participation in this research?

Eligible applicants for this trial must be aged 18 to 80. There are 4 trials specifically designed for patients that are under the age of 18 and 111 trials available for patients 65 years or older.

Q: What are the lofty goals of this research?

The purpose of this trial is to monitor the number of participants with neurological complications (TIA, <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a>) over a period of 6 months. Secondary outcomes include successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device. Other efficacy outcomes include thrombosis of the false lumen within the confines of the device, and assessment of need for stent removal.

Q: Can patients still sign up for this research program?

The clinical trial in question is not accepting patients at this time. It was initially posted on 3/5/2017, and the last update was on 2/25/2022. There are 114 other trials that are currently looking for participants.

N/A

Waitlist Available

Led By Jessica Forcillo, MD

Research Sponsored by Ascyrus Medical LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up annually, through study completion, an average of 5 years

Awards & highlights

DARTS I Trial Summary

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

Who is the study for?

This trial is for adults under 80 with a recent (0-14 days) acute DeBakey type I dissection or intramural hematoma based on CT angiography. Excluded are those allergic to Nitinol/PTFE, in severe hemodynamic compromise, pregnant/breastfeeding, unwilling to follow up, with systemic infections, anaphylaxis to iodinated contrast, life expectancy <2 years, certain genetic syndromes or extensive aortic arch issues.Check my eligibility

What is being tested?

The DARTS I study tests the AMDS device's feasibility and benefits for open surgical repair of acute DeBakey type I dissections/intramural hematomas involving the ascending aorta and arch. It aims to understand how well this treatment works in these emergency conditions.See study design

What are the potential side effects?

While specific side effects of AMDS aren't listed here, similar devices may cause complications like infection risk at the surgery site, bleeding issues due to blood vessel damage during insertion or removal of the device.

DARTS I Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ annually, through study completion, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~annually, through study completion, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and annually, through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with device-related mortality

Number of participants with neurological complications (TIA, stroke)

Secondary outcome measures

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

+1 more

Other outcome measures

AMDS related re-interventions after the dissection repair

Aortic arch branch vessel patency

Aortic injury associated with the implantation of the device

DARTS I Trial Design

1Treatment groups

Experimental Treatment

Group I: AMDS ImplantationExperimental Treatment1 Intervention

AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ascyrus Medical LLC.Lead Sponsor

2 Previous Clinical Trials

307 Total Patients Enrolled

2 Trials studying Aortic Dissection

307 Patients Enrolled for Aortic Dissection

Artivion Inc.Industry Sponsor

5 Previous Clinical Trials

1,297 Total Patients Enrolled

2 Trials studying Aortic Dissection

100 Patients Enrolled for Aortic Dissection

Jessica Forcillo, MDPrincipal InvestigatorCentre Hospitalier de I'Universite de Montreal

Media Library

AMDS (Aortic Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT03035643 — N/A

Aortic Dissection Research Study Groups: AMDS Implantation

Aortic Dissection Clinical Trial 2023: AMDS Highlights & Side Effects. Trial Name: NCT03035643 — N/A

AMDS (Aortic Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03035643 — N/A

Frequently Asked Questions

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

Is this clinical test being conducted in more than one hospital within the city limits?

"This trial is currently recruiting at 5 different locations, these include University Health Network - Toronto General Hospital in Toronto, Montreal Heart Institute in Montréal, and London Health Sciences Center- University Hospital in London among others."

Answered by AI

For which patients is this experimental treatment being made available?

"This research study is investigating aortic dissection and thus, participants must have this condition to be eligible. The age limit for potential subjects is 18-80 years old and the trial will enroll 40 individuals in total."

Answered by AI

Are the elderly eligible for participation in this research?

"Eligible applicants for this trial must be aged 18 to 80. There are 4 trials specifically designed for patients that are under the age of 18 and 111 trials available for patients 65 years or older."

Answered by AI

What are the lofty goals of this research?

"The purpose of this trial is to monitor the number of participants with neurological complications (TIA, stroke) over a period of 6 months. Secondary outcomes include successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device. Other efficacy outcomes include thrombosis of the false lumen within the confines of the device, and assessment of need for stent removal."

Answered by AI

Can patients still sign up for this research program?

"The clinical trial in question is not accepting patients at this time. It was initially posted on 3/5/2017, and the last update was on 2/25/2022. There are 114 other trials that are currently looking for participants."

Answered by AI

Recent research and studies

Interactive CardioVascular and Thoracic SurgeryJournal

Initial Experience with the New Type A Arch Dissection Stent: Restoration of Supra-aortic Vessel Perfusion

Montagner, Matteo, Markus Kofler, Roland Heck, Semih Buz, Christoph Starck, Stephan Kurz, Volkmar Falk, and Jörg Kempfert. 2021. “Initial Experience with the New Type A Arch Dissection Stent: Restoration of Supra-aortic Vessel Perfusion”. Interactive Cardiovascular and Thoracic Surgery. Oxford University Press (OUP). doi:10.1093/icvts/ivab085.

The Annals of Thoracic SurgeryJournal

Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial

Bozso, Sabin J., Jeevan Nagendran, Michael W.A. Chu, Bob Kiaii, Ismail El-Hamamsy, Maral Ouzounian, Jörg Kempfert, Christoph Starck, and Michael C. Moon. 2021. “Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2020.05.090.

The Annals of Thoracic SurgeryJournal

Single-stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft

Bozso, Sabin J., Jeevan Nagendran, Michael W.A. Chu, Bob Kiaii, Ismail El-Hamamsy, Maral Ouzounian, Jörg Kempfert, Christoph Starck, Ali Shahriari, and Michael C. Moon. 2019. “Single-stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2019.04.121.

The Journal of Thoracic and Cardiovascular SurgeryJournal