Acute DeBakey I 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, Safety and Performance trial 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 30 subjects will be enrolled at 1 site in Germany. The enrollment period will span a minimum of 3 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 the AMDS
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Informed Consent obtained 2. ≥18 years of age or ≤80 years of age (male or female) Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days: 3. Acute DeBakey I dissection or 4. Acute DeBakey I intramural hematoma (IMH)
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aortic arch branch vessel patency | 12 weeks | The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device |
| Number of participants with treatment-related mortality | 12 weeks | The number of patients with mortality related to the treatment device |
| Number of participants with treatment-related neurological deficit | 12 weeks | The number of patients with neurological complications related to the treatment device |
| Number of patients with aortic injury associated with the implantation of the device | 12 weeks | The number of patients with aortic injury related to the treatment device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related mortality | 24 weeks and 12 months | The number of patients with mortality related to the device and procedure |
| Number of participants with treatment-related neurological deficit | 24 weeks and 12 months | The number of patients with neurological complications, such as stroke, TIA, and paralysis/paraplegia) related to the treatment device |
| Number of patients with aortic injury associated with the implantation of the device | 24 weeks and 12 months | The number of patients with aortic injury related to the treatment device |
| Aortic arch branch vessel patency | 24 weeks and 12 months | The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device |
Other
| Measure | Time frame | Description |
|---|---|---|
| Circulatory arrest duration | 12 weeks, 24 weeks, and 12 months | The total time (in minutes) of circulatory arrest for patients undergoing AMDS implantation |
| Time in ICU | 12 weeks, 24 weeks, and 12 months | The total amount of days for patients that have undergo aortic dissection repair with AMDS implantation |
| Re-expansion of the true lumen | 12 weeks, 24 weeks, and 12 months | The number of patients with achieved re-expansion of the true lumen following AMDS implantation |
| AMDS procedure duration | 12 weeks, 24 weeks, and 12 months | The total amount of time (in minutes) that it takes for AMDS to be implanted |
| Duration of hospitalization | 12 weeks, 24 weeks, and 12 months | The total number of days of hospitalization required for patients undergoing AMDS implantation |
| False lumen reattachment/positive remodeling | 12 weeks, 24 weeks, and 12 months | The number of patients which exhibit positive remodeling/false lumen reattachment as measured by CT. |
| False Lumen Thrombosis | 12 weeks, 24 weeks, and 12 months | The percentage of patients with evidence of false lumen thrombosis within the confinement of the AMDS, distal to the AMDS but proximal to the Celiac trunk, along the paravisceral aorta and in the infrarenal aorta. |
| Stent-graft integrity Assessment | 12 weeks, 24 weeks, and 12 months | The percentage of patients without evidence of stent-graft fractures, kinking, or twisting leading to occlusion or ischemia in patients that have undergone aortic dissection repair with AMDS. Stent graft integrity will be evaluated by CTA with a Core Imaging Lab. |
| Successful device deployment | 12 weeks, 24 weeks, and 12 months | The number of patients which had successful device deployment |
| AMDS removal | 12 weeks, 24 weeks, and 12 months | The percentage of patients that required AMDS removal |
| AMDS related re-interventions after the dissection repair | 12 weeks, 24 weeks, and 12 months | The percentage of patients with need of secondary intervention related to the AMDS implantation following the index procedure for aortic dissection repair |
| Cardiopulmonary bypass (CBP) duration | 12 weeks, 24 weeks, and 12 months | The total time (in minutes) of CBP required for patients undergoing AMDS implantation |
Countries
Germany
Outcome results
None listed