DARTS I: Feasibility, Safety, and Performance Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AMDS Implantation AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair. |
Device: AMDS
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Aortic arch branch vessel patency [12 weeks]
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
Secondary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- Duration of hospitalization [12 weeks, 24 weeks, and 12 months]
The total number of days of hospitalization required for patients undergoing 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
Eligibility Criteria
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:
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Acute DeBakey I dissection or
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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:
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Less than 18 years of age or over 80 years of age
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Life expectancy less than 2 years
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Pregnant or breastfeeding or planning on becoming pregnant within 60 months
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Unwilling to comply with the follow-up schedule
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Refusal to give informed consent
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Institutionalized individualized due to administrative or judicial order
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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:
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Uncontrolled systemic infection
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Uncontrollable anaphylaxis to iodinated contrast
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Known allergy(ies) to Nitinol and/or PTFE
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Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
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Inability to obtain CT angiograms for follow-up
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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
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Any pathology of mycotic origin
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Subacute or chronic dissection of the ascending aorta and aortic arch (>14 days after the index event)
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Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
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Extensive thrombus or calcifications in the aortic arch as defined by CT angiography
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Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
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Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring > 45mm in diameter
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Aortic arch aneurysm > 45mm in diameter
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Deutsches Hertzzentrum Berlin | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Ascyrus Medical LLC.
- Artivion Inc.
Investigators
- Principal Investigator: Jorg Kempfert, MD, German Heart Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Moon MC. Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial. Ann Thorac Surg. 2021 Feb;111(2):463-470. doi: 10.1016/j.athoracsur.2020.05.090. Epub 2020 Jul 13.
- Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Shahriari A, Moon MC. Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. Ann Thorac Surg. 2019 Dec;108(6):1768-1775. doi: 10.1016/j.athoracsur.2019.04.121. Epub 2019 Jun 27.
- Montagner M, Kofler M, Heck R, Buz S, Starck C, Kurz S, Falk V, Kempfert J. Initial experience with the new type A arch dissection stent: restoration of supra-aortic vessel perfusion. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):276-283. doi: 10.1093/icvts/ivab085.
- DARTS-AMDS