Aortic Dissection Clinical Trial
— DARTS IOfficial title:
Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study
Verified date | February 2024 |
Source | Artivion Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | February 29, 2024 |
Est. primary completion date | August 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days: 1. Acute DeBakey type I dissection or 2. Acute DeBakey type I intramural hematoma (IMH) Exclusion Criteria: General Exclusion Criteria Patients must be excluded from the study if any of the following conditions are true: 1. Less than 18 years of age or over 80 years of age 2. Life expectancy less than 2 years 3. Pregnant or breastfeeding or planning on becoming pregnant within 60 months 4. Unwilling to comply with the follow-up schedule 5. Refusal to give informed consent Medical Exclusion Criteria Patients must be excluded from the study if any of the following conditions are true: 1. Uncontrolled systemic infection 2. Uncontrollable anaphylaxis to iodinated contrast 3. Known allergy(ies) to Nitinol and/or PTFE 4. Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) 5. Inability to obtain CT angiograms for follow-up 6. 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 1. Any pathology of mycotic origin 2. Subacute or chronic dissection of the ascending aorta and aortic arch (>14 days after the index event) 3. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial) 4. Extensive thrombus or calcifications in the aortic arch as defined by CT angiography 5. Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography 6. Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring > 45mm in diameter. |
Country | Name | City | State |
---|---|---|---|
Canada | Mazankowski Alberta Heart Institute, University of Alberta | Edmonton | Alberta |
Canada | London Health Sciences Center- University Hospital | London | Ontario |
Canada | Centre Hospitalier de I'Universite de Montreal (CHUM) | Montréal | Quebec |
Canada | Montreal Heart Institute | Montréal | Quebec |
Canada | University Health Network - Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ascyrus Medical LLC. | Artivion Inc. |
Canada,
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. — View Citation
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. — View Citation
Bozso SJ, Nagendran J, MacArthur RGG, Chu MWA, Kiaii B, El-Hamamsy I, Cartier R, Shahriari A, Moon MC. Dissected Aorta Repair Through Stent Implantation trial: Canadian results. J Thorac Cardiovasc Surg. 2019 May;157(5):1763-1771. doi: 10.1016/j.jtcvs.2018.09.120. Epub 2018 Oct 26. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Aortic injury associated with the implantation of the device | The number of patients which has any aortic injury(ies) associated with the implantation of AMDS | Annually, through study completion, an average of 5 years | |
Other | Aortic arch branch vessel patency | An evaluation of the patency of aortic arch branch vessels for patients which have had AMDS implantation. Aortic arch branch vessel patency will be evaluated by CTA with a Core Imaging Lab. | Annually, through study completion, an average of 5 years | |
Other | AMDS related re-interventions after the dissection repair | The number of patients which have required re-interventions related to the AMDS implantation following the index procedure for aortic dissection repair. | Annually, through study completion, an average of 5 years | |
Primary | Number of participants with device-related mortality | The number of patients with mortality related to the treatment device | Early (within 30 days) | |
Primary | Number of participants with device-related mortality | The number of patients with mortality related to the treatment device | Intermediate (3 months) | |
Primary | Number of participants with device-related mortality | The number of patients with mortality related to the treatment device | Late (6 months) | |
Primary | Number of participants with neurological complications (TIA, stroke) | The number of patients with neurological complications related to the treatment device | Early (within 30 days) | |
Primary | Number of participants with neurological complications (TIA, stroke) | The number of patients with neurological complications related to the treatment device | Intermediate (3 months) | |
Primary | Number of participants with neurological complications (TIA, stroke) | The number of patients with neurological complications related to the treatment device | Late (6 months) | |
Secondary | Thrombosis of the false lumen within the confines of the device | Efficacy outcome: Number of participants with false lumen exclusion within the treatment area confined by the treatment device. | Annually, through study completion, an average of 5 years | |
Secondary | Assess need for stent removal | Stent placement and retention. The number of patients requiring removal of the stent. | Annually, through study completion, an average of 5 years | |
Secondary | Successful reattachment of the intimal flap within the arch | The number of patients that has successful reattachment of the intimal flap within the arch following the implantation of AMDS | Annually, through study completion, an average of 5 years | |
Secondary | Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device | The number of patients which has successful AMDS deployment and which also had radiographic evidence of false lumen exclusion within the confines of AMDS | Annually, through study completion, an average of 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05582967 -
The DAShED (Diagnosis of Aortic Syndrome in the ED) Study
|
||
Terminated |
NCT04116684 -
Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients
|
N/A | |
Completed |
NCT02086136 -
Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection
|
||
Recruiting |
NCT02201589 -
Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
|
N/A | |
Recruiting |
NCT03948555 -
Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation
|
||
Enrolling by invitation |
NCT05912608 -
Optimal Strategy for Repair of Type A Acute Aortic Dissection
|
||
Recruiting |
NCT03707743 -
Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)
|
||
Enrolling by invitation |
NCT00583817 -
Endovascular Treatment of Thoracic Aortic Disease
|
N/A | |
Recruiting |
NCT05073991 -
Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
|
||
Not yet recruiting |
NCT02523300 -
Glucocorticoid on the Prognosis of TEVAR
|
N/A | |
Completed |
NCT01197651 -
Aortic-Stent-Register
|
N/A | |
Recruiting |
NCT04471909 -
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
|
N/A | |
Not yet recruiting |
NCT06044259 -
Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection
|
N/A | |
Completed |
NCT05039814 -
Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C
|
||
Recruiting |
NCT03780738 -
A Validation Study of The Relationship Between ALDH2 and Aortic Dissection
|
||
Completed |
NCT03647566 -
18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
|
||
Enrolling by invitation |
NCT05800743 -
Evaluation of the GORE® Ascending Stent Graft
|
N/A | |
Recruiting |
NCT03347812 -
Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair
|
N/A | |
Completed |
NCT05044494 -
Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
|
||
Terminated |
NCT02958098 -
My Research Legacy Pilot Study
|