DARTS I Feasibility Study

NCT ID: NCT03035643

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-05
• Study Completion Date: 2024-03-19

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.

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.

Conditions

Aortic Dissection; Intramural Hematoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMDS Implantation

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

Group Type: EXPERIMENTAL

AMDS

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Artivion Inc.

INDUSTRY

Sponsor Role: collaborator

Ascyrus Medical LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Forcillo, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de I'Universite de Montreal

Maral Ouzounian, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network - Toronto General Hospital

Michael Chu, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Science Center

Philippe Demers

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Michael Moon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Mazankowski Alberta Heart Institute, University of Alberta

Edmonton, Alberta, Canada

London Health Sciences Center- University Hospital

London, Ontario, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Centre Hospitalier de I'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 32673661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30501947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31254509 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34010408 (View on PubMed)

Other Identifiers

Pro00066039_AME3

Identifier Type: -

Identifier Source: org_study_id