Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute DeBakey I Aortic Dissection
- Sponsor
- Ascyrus Medical LLC.
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related neurological deficit
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed Consent obtained
- •≥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:
- •Acute DeBakey I dissection or
- •Acute DeBakey I intramural hematoma (IMH)
Exclusion Criteria
- •General Exclusion Criteria
- •Patients must be excluded from the study if any of the following conditions are true:
- •Less than 18 years of age or over 80 years of age
- •Life expectancy less than 2 years
- •Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- •Unwilling to comply with the follow-up schedule
- •Refusal to give informed consent
- •Institutionalized individualized due to administrative or judicial order
- •Individuals with a dependent relationship to the sponsor or investigator
- •Medical Exclusion Criteria
Outcomes
Primary Outcomes
Number of participants with treatment-related neurological deficit
Time Frame: 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
Time Frame: 12 weeks
The number of patients with aortic injury related to the treatment device
Number of participants with treatment-related mortality
Time Frame: 12 weeks
The number of patients with mortality related to the treatment device
Aortic arch branch vessel patency
Time Frame: 12 weeks
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
Secondary Outcomes
- Number of participants with treatment-related mortality(24 weeks and 12 months)
- Number of patients with aortic injury associated with the implantation of the device(24 weeks and 12 months)
- Number of participants with treatment-related neurological deficit(24 weeks and 12 months)
- Aortic arch branch vessel patency(24 weeks and 12 months)