Aortic Dissection, Intramural Hematoma
Conditions
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.
Interventions
DEVICEAMDS
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.
Sponsors
Artivion Inc.
Ascyrus Medical LLC.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of AMDS
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with device-related mortality | Early (within 30 days) | The number of patients with mortality related to the treatment device |
| Number of participants with neurological complications (TIA, stroke) | Early (within 30 days) | The number of patients with neurological complications related to the treatment device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess need for stent removal | Annually, through study completion, an average of 5 years | Stent placement and retention. The number of patients requiring removal of the stent. |
| Thrombosis of the false lumen within the confines of the device | Annually, through study completion, an average of 5 years | Efficacy outcome: Number of participants with false lumen exclusion within the treatment area confined by the treatment device. |
| Successful reattachment of the intimal flap within the arch | Annually, through study completion, an average of 5 years | The number of patients that has successful reattachment of the intimal flap within the arch following the implantation of AMDS |
| 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 | The number of patients which has successful AMDS deployment and which also had radiographic evidence of false lumen exclusion within the confines of AMDS |
Other
| Measure | Time frame | Description |
|---|---|---|
| Aortic arch branch vessel patency | Annually, through study completion, an average of 5 years | 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. |
| Aortic injury associated with the implantation of the device | Annually, through study completion, an average of 5 years | The number of patients which has any aortic injury(ies) associated with the implantation of AMDS |
| AMDS related re-interventions after the dissection repair | Annually, through study completion, an average of 5 years | The number of patients which have required re-interventions related to the AMDS implantation following the index procedure for aortic dissection repair. |
Countries
Canada
Outcome results
None listed