DARTS I: Feasibility, Safety, and Performance Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial

Conditions
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Acute DeBakey I Aortic Dissection, Intramural Hematoma

Intervention / Treatment
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* Device: AMDS


Participation Criteria
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Eligibility Criteria
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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 Patients must be excluded from the study if any of the following conditions are true: Uncontrolled systemic infection Uncontrollable anaphylaxis to iodinated contrast Known allergy(ies) to Nitinol and/or PTFE Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) Inability to obtain CT angiograms for follow-up 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 Any pathology of mycotic origin Subacute or chronic dissection of the ascending aorta and aortic arch (>14 days after the index event) Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial) Extensive thrombus or calcifications in the aortic arch as defined by CT angiography Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring > 45mm in diameter Aortic arch aneurysm > 45mm in diameter

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of the AMDS
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMDS Implantation<br>AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair. | Device: AMDS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related mortality | The number of patients with mortality related to the treatment device | 12 weeks | 
| Number of participants with treatment-related neurological deficit | The number of patients with neurological complications related to the treatment device | 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 | 12 weeks | 
| Aortic arch branch vessel patency | The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related mortality | The number of patients with mortality related to the device and procedure | 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 | 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 | 24 weeks and 12 months | 
| Aortic arch branch vessel patency | The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device | 24 weeks and 12 months |