Clinical trial NCT03035643: DARTS I Feasibility Study
Official title: Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Dissection
Intramural Hematoma
Lead sponsor: Artivion Inc.
Sponsor class: INDUSTRY
Collaborators: name: Artivion Inc.
First posted: 2017-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of AMDS
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Number of participants with device-related mortality
timeFrame: Early (within 30 days)
measure: Number of participants with device-related mortality
timeFrame: Intermediate (3 months)
measure: Number of participants with device-related mortality
timeFrame: Late (6 months)
measure: Number of participants with neurological complications (TIA, stroke)
timeFrame: Early (within 30 days)
measure: Number of participants with neurological complications (TIA, stroke)
timeFrame: Intermediate (3 months)
measure: Number of participants with neurological complications (TIA, stroke)
timeFrame: Late (6 months)
Secondary outcomes:
measure: Thrombosis of the false lumen within the confines of the device
timeFrame: Annually, through study completion, an average of 5 years
measure: Assess need for stent removal
timeFrame: Annually, through study completion, an average of 5 years
measure: Successful reattachment of the intimal flap within the arch
timeFrame: Annually, through study completion, an average of 5 years
measure: Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device
timeFrame: Annually, through study completion, an average of 5 years
Other outcomes:
measure: Aortic injury associated with the implantation of the device
timeFrame: Annually, through study completion, an average of 5 years
measure: Aortic arch branch vessel patency
timeFrame: Annually, through study completion, an average of 5 years
measure: AMDS related re-interventions after the dissection repair
timeFrame: Annually, through study completion, an average of 5 years
Locations:
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute, University of Alberta
state: Alberta
city: London
country: Canada
facility: London Health Sciences Center- University Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de I'Universite de Montreal (CHUM)
state: Quebec
Study officials:
affiliation: Centre Hospitalier de I'Universite de Montreal
name: Jessica Forcillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network - Toronto General Hospital
name: Maral Ouzounian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Science Center
name: Michael Chu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart Institute
name: Philippe Demers
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Michael Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.