An interventional study of AMDS in Acute DeBakey I Aortic Dissection and Intramural Hematoma, sponsored by Ascyrus Medical LLC.. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Ascyrus Medical LLC. · Not applicable, Interventional, and Treatment
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.
109 studies on the registry are indexed under Hematoma; 19 are open to participants now.
This study's enrollment of 7 is below the median of 107 across 83 interventional studies indexed under Hematoma.
Browse Hematoma studies →Ascyrus Medical LLC. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
≥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:
Exclusion Criteria:
General Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
Medical Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
Anatomical Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
Re-expansion of the true lumen
The number of patients with achieved re-expansion of the true lumen following AMDS implantation
Time frame: 12 weeks, 24 weeks, and 12 months
False lumen reattachment/positive remodeling
The number of patients which exhibit positive remodeling/false lumen reattachment as measured by CT.
Time frame: 12 weeks, 24 weeks, and 12 months
False Lumen Thrombosis
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.
Time frame: 12 weeks, 24 weeks, and 12 months
Stent-graft integrity Assessment
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.
Time frame: 12 weeks, 24 weeks, and 12 months
Successful device deployment
The number of patients which had successful device deployment
Time frame: 12 weeks, 24 weeks, and 12 months
AMDS removal
The percentage of patients that required AMDS removal
Time frame: 12 weeks, 24 weeks, and 12 months
AMDS related re-interventions after the dissection repair
The percentage of patients with need of secondary intervention related to the AMDS implantation following the index procedure for aortic dissection repair
Time frame: 12 weeks, 24 weeks, and 12 months
Cardiopulmonary bypass (CBP) duration
The total time (in minutes) of CBP required for patients undergoing AMDS implantation
Time frame: 12 weeks, 24 weeks, and 12 months
Circulatory arrest duration
The total time (in minutes) of circulatory arrest for patients undergoing AMDS implantation
Time frame: 12 weeks, 24 weeks, and 12 months
Time in ICU
The total amount of days for patients that have undergo aortic dissection repair with AMDS implantation
Time frame: 12 weeks, 24 weeks, and 12 months
Duration of hospitalization
The total number of days of hospitalization required for patients undergoing AMDS implantation
Time frame: 12 weeks, 24 weeks, and 12 months
AMDS procedure duration
The total amount of time (in minutes) that it takes for AMDS to be implanted
Time frame: 12 weeks, 24 weeks, and 12 months
Plan to share: No
Ran from Mar 2018 to primary completion in Sep 2018, 6 months.
Of 34 interventional studies with no phase under Hematoma, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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