DARTS I Feasibility Study (DARTS I)

Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Dissection; Intramural Hematoma
• Intervention / Treatment: Device: AMDS

Detailed Description

AMDS is designed to complement the replacement of the ascending aorta with conventional surgical technique utilizing a conventional polyester graft. AMDS is constructed of an uncovered Nitinol wire braided stent attached proximally to a polytetrafluoroethylene (PTFE) felt graft component. The PFTE felt graft component excludes the FL at the distal aortic anastomosis and the wire stent re-expands the dissection flap within the arch and descending aorta, which aims to treat malperfusion and promote positive remodeling of the aorta.

The DARTS I Feasibility study is a prospective, non-randomized, non-blinded, single-arm, multi-institutional Canadian study evaluating the feasibility and safety of the AMDS graft. A goal of 40 subjects will be enrolled at approximately 5 sites in Canada.

The enrollment period will span a minimum of 12 months from Institutional Review Board (IRB) approval and site activation. Candidates for this study are adults who require repair of an acute DeBakey type I aorta dissection and/or intramural hematoma (IMH). Patients will be consented pre-operatively and enrolled patients will be followed for approximately 5 years after their AMDS implantation date. Data will be collected at 10 time points: baseline (pre-operatively), discharge, 1 month post-operatively, 3 months post-operatively, and 6 months post-operatively, 1 year post-operatively and thereafter, annually, for a total of 5 years.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Mazankowski Alberta Heart Institute, University of Alberta
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Center- University Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network - Toronto General Hospital
  • Quebec
    • Montréal, Quebec, Canada, HIT 1C8
      • Montreal Heart Institute
    • Montréal, Quebec, Canada
      • Centre Hospitalier de I'Universite de Montreal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:

1. Acute DeBakey type I dissection or
2. Acute DeBakey type I intramural hematoma (IMH)

Exclusion Criteria:

General Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

1. Less than 18 years of age or over 80 years of age
2. Life expectancy less than 2 years
3. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
4. Unwilling to comply with the follow-up schedule
5. Refusal to give informed consent

Medical Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

1. Uncontrolled systemic infection
2. Uncontrollable anaphylaxis to iodinated contrast
3. Known allergy(ies) to Nitinol and/or PTFE
4. Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
5. Inability to obtain CT angiograms for follow-up
6. 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

Anatomical Exclusion Criteria

1. Any pathology of mycotic origin
2. Subacute or chronic dissection of the ascending aorta and aortic arch (>14 days after the index event)
3. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
4. Extensive thrombus or calcifications in the aortic arch as defined by CT angiography
5. Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
6. Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring > 45mm in diameter.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMDS Implantation; AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.	Device: AMDS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombosis of the false lumen within the confines of the device	Efficacy outcome: Number of participants with false lumen exclusion within the treatment area confined by the treatment device.	Annually, through study completion, an average of 5 years
Assess need for stent removal	Stent placement and retention. The number of patients requiring removal of the stent.	Annually, through study completion, an average of 5 years
Successful reattachment of the intimal flap within the arch	The number of patients that has successful reattachment of the intimal flap within the arch following the implantation of AMDS	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	The number of patients which has successful AMDS deployment and which also had radiographic evidence of false lumen exclusion within the confines of AMDS	Annually, through study completion, an average of 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aortic injury associated with the implantation of the device	The number of patients which has any aortic injury(ies) associated with the implantation of AMDS	Annually, through study completion, an average of 5 years
Aortic arch branch vessel patency	An evaluation of the patency of aortic arch branch vessels for patients which have had AMDS implantation. Aortic arch branch vessel patency will be evaluated by CTA with a Core Imaging Lab.	Annually, through study completion, an average of 5 years
AMDS related re-interventions after the dissection repair	The number of patients which have required re-interventions related to the AMDS implantation following the index procedure for aortic dissection repair.	Annually, through study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: Ascyrus Medical LLC.
• Collaborators: Artivion Inc.
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2017
• Primary Completion (Actual): August 21, 2019
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimated): January 30, 2017

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hemorrhage; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Hematoma; Aortic Dissection
• Other Study ID Numbers: Pro00066039_AME3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No