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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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.
Deutsches Hertzzentrum Berlin
Berlin, Germany
Number of participants with treatment-related mortality
The number of patients with mortality related to the treatment device
Time frame: 12 weeks
Number of participants with treatment-related neurological deficit
The number of patients with neurological complications related to the treatment device
Time frame: 12 weeks
Number of patients with aortic injury associated with the implantation of the device
The number of patients with aortic injury related to the treatment device
Time frame: 12 weeks
Aortic arch branch vessel patency
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
Time frame: 12 weeks
Number of participants with treatment-related mortality
The number of patients with mortality related to the device and procedure
Time frame: 24 weeks and 12 months
Number of participants with treatment-related neurological deficit
The number of patients with neurological complications, such as stroke, TIA, and paralysis/paraplegia) related to the treatment device
Time frame: 24 weeks and 12 months
Number of patients with aortic injury associated with the implantation of the device
The number of patients with aortic injury related to the treatment device
Time frame: 24 weeks and 12 months
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Aortic arch branch vessel patency
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
Time frame: 24 weeks and 12 months