DARTS I Feasibility Study

NCT03035643 | Completed DMC

• 1 other identifier: Pro00066039_AME3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this study is to investigate the feasibility and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas (IMH) involving the ascending aorta and aortic arch through open surgical repair.

Conditions

Aortic Dissection; Intramural Hematoma

Outcome Measures

Primary Outcomes (6)

• Number of participants with device-related mortality

  The number of patients with mortality related to the treatment device

  Early (within 30 days)

• Number of participants with device-related mortality

  The number of patients with mortality related to the treatment device

  Intermediate (3 months)

• Number of participants with device-related mortality

  The number of patients with mortality related to the treatment device

  Late (6 months)

• Number of participants with neurological complications (TIA, stroke)

  The number of patients with neurological complications related to the treatment device

  Early (within 30 days)

• Number of participants with neurological complications (TIA, stroke)

  The number of patients with neurological complications related to the treatment device

  Intermediate (3 months)

• Number of participants with neurological complications (TIA, stroke)

  The number of patients with neurological complications related to the treatment device

  Late (6 months)

Secondary Outcomes (4)

• Thrombosis of the false lumen within the confines of the device

  Annually, through study completion, an average of 5 years

• Assess need for stent removal

  Annually, through study completion, an average of 5 years

• Successful reattachment of the intimal flap within the arch

  Annually, through study completion, an average of 5 years

• Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device

  Annually, through study completion, an average of 5 years

Other Outcomes (3)

• Aortic injury associated with the implantation of the device

  Annually, through study completion, an average of 5 years

• Aortic arch branch vessel patency

  Annually, through study completion, an average of 5 years

• AMDS related re-interventions after the dissection repair

  Annually, through study completion, an average of 5 years

Study Arms (1)

AMDS Implantation

EXPERIMENTAL

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

Device: AMDS

Interventions

AMDS DEVICE

The device will be implanted during an already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.

AMDS Implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:
• Acute DeBakey type I dissection or
• Acute DeBakey type I intramural hematoma (IMH)

You may not qualify if:

• Patients must be excluded from the study if any of the following conditions are true:
• Less than 18 years of age or over 80 years of age
• Life expectancy less than 2 years
• Pregnant or breastfeeding or planning on becoming pregnant within 60 months
• Unwilling to comply with the follow-up schedule
• Refusal to give informed consent
• Patients must be excluded from the study if any of the following conditions are true:
• Uncontrolled systemic infection
• Uncontrollable anaphylaxis to iodinated contrast
• Known allergy(ies) to Nitinol and/or PTFE
• Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
• Inability to obtain CT angiograms for follow-up
• Previously diagnosed with Marfan syndrome, Loeys- Dietz syndrome or Ehlers- Danlos syndrome with confirmed laboratory genetic testing on a date prior to the diagnosis of the dissection
• Any pathology of mycotic origin
• Subacute or chronic dissection of the ascending aorta and aortic arch (\>14 days after the index event)

Sponsors & Collaborators

• Ascyrus Medical LLC.: lead
• Artivion Inc.: collaborator

Study Sites (5)

Mazankowski Alberta Heart Institute, University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

London Health Sciences Center- University Hospital

London, Ontario, N6A 5A5, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, HIT 1C8, Canada

Location

Centre Hospitalier de I'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Location

Related Publications (4)

• Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Moon MC. Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial. Ann Thorac Surg. 2021 Feb;111(2):463-470. doi: 10.1016/j.athoracsur.2020.05.090. Epub 2020 Jul 13.

  PMID: 32673661 BACKGROUND

• Bozso SJ, Nagendran J, MacArthur RGG, Chu MWA, Kiaii B, El-Hamamsy I, Cartier R, Shahriari A, Moon MC. Dissected Aorta Repair Through Stent Implantation trial: Canadian results. J Thorac Cardiovasc Surg. 2019 May;157(5):1763-1771. doi: 10.1016/j.jtcvs.2018.09.120. Epub 2018 Oct 26.

  PMID: 30501947 BACKGROUND

• Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Shahriari A, Moon MC. Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. Ann Thorac Surg. 2019 Dec;108(6):1768-1775. doi: 10.1016/j.athoracsur.2019.04.121. Epub 2019 Jun 27.

  PMID: 31254509 BACKGROUND

• Montagner M, Kofler M, Heck R, Buz S, Starck C, Kurz S, Falk V, Kempfert J. Initial experience with the new type A arch dissection stent: restoration of supra-aortic vessel perfusion. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):276-283. doi: 10.1093/icvts/ivab085.

  PMID: 34010408 BACKGROUND

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Jessica Forcillo, MD

  Centre Hospitalier de I'Universite de Montreal

  PRINCIPAL INVESTIGATOR

• Maral Ouzounian, MD

  University Health Network - Toronto General Hospital

  PRINCIPAL INVESTIGATOR

• Michael Chu, MD

  London Health Science Center

  PRINCIPAL INVESTIGATOR

• Philippe Demers

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Michael Moon, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of AMDS

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 30, 2017
• Study Start: March 5, 2017
• Primary Completion: August 21, 2019
• Study Completion: March 19, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)