Back to resultsDARTS I: Feasibility, Safety, and Performance Trial (DARTS I)
Primary Purpose
Acute DeBakey I Aortic Dissection, Intramural Hematoma
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
AMDS
Sponsored by
About this trial
This is an interventional treatment trial for Acute DeBakey I Aortic Dissection
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
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
Sites / Locations
- Deutsches Hertzzentrum Berlin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AMDS Implantation
Arm Description
AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.
Outcomes
Primary Outcome Measures
Number of participants with treatment-related mortality
The number of patients with mortality related to the treatment device
Number of participants with treatment-related neurological deficit
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
The number of patients with aortic injury related to the treatment device
Aortic arch branch vessel patency
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
The number of patients with mortality related to the device and procedure
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
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
Aortic arch branch vessel patency
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
Full Information
NCT ID
NCT03397251
First Posted
January 6, 2018
Last Updated
February 25, 2022
Sponsor
Ascyrus Medical LLC.
Collaborators
Artivion Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03397251
Brief Title
DARTS I: Feasibility, Safety, and Performance Trial
Acronym
DARTS I
Official Title
Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascyrus Medical LLC.
Collaborators
Artivion Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute DeBakey I Aortic Dissection, Intramural Hematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of the AMDS
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMDS Implantation
Arm Type
Experimental
Arm Description
AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.
Intervention Type
Device
Intervention Name(s)
AMDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related mortality
Description
The number of patients with mortality related to the treatment device
Time Frame
12 weeks
Title
Number of participants with treatment-related neurological deficit
Description
The number of patients with neurological complications related to the treatment device
Time Frame
12 weeks
Title
Number of patients with aortic injury associated with the implantation of the device
Description
The number of patients with aortic injury related to the treatment device
Time Frame
12 weeks
Title
Aortic arch branch vessel patency
Description
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related mortality
Description
The number of patients with mortality related to the device and procedure
Time Frame
24 weeks and 12 months
Title
Number of participants with treatment-related neurological deficit
Description
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
Title
Number of patients with aortic injury associated with the implantation of the device
Description
The number of patients with aortic injury related to the treatment device
Time Frame
24 weeks and 12 months
Title
Aortic arch branch vessel patency
Description
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
Time Frame
24 weeks and 12 months
Other Pre-specified Outcome Measures:
Title
Re-expansion of the true lumen
Description
The number of patients with achieved re-expansion of the true lumen following AMDS implantation
Time Frame
12 weeks, 24 weeks, and 12 months
Title
False lumen reattachment/positive remodeling
Description
The number of patients which exhibit positive remodeling/false lumen reattachment as measured by CT.
Time Frame
12 weeks, 24 weeks, and 12 months
Title
False Lumen Thrombosis
Description
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
Title
Stent-graft integrity Assessment
Description
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
Title
Successful device deployment
Description
The number of patients which had successful device deployment
Time Frame
12 weeks, 24 weeks, and 12 months
Title
AMDS removal
Description
The percentage of patients that required AMDS removal
Time Frame
12 weeks, 24 weeks, and 12 months
Title
AMDS related re-interventions after the dissection repair
Description
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
Title
Cardiopulmonary bypass (CBP) duration
Description
The total time (in minutes) of CBP required for patients undergoing AMDS implantation
Time Frame
12 weeks, 24 weeks, and 12 months
Title
Circulatory arrest duration
Description
The total time (in minutes) of circulatory arrest for patients undergoing AMDS implantation
Time Frame
12 weeks, 24 weeks, and 12 months
Title
Time in ICU
Description
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
Title
Duration of hospitalization
Description
The total number of days of hospitalization required for patients undergoing AMDS implantation
Time Frame
12 weeks, 24 weeks, and 12 months
Title
AMDS procedure duration
Description
The total amount of time (in minutes) that it takes for AMDS to be implanted
Time Frame
12 weeks, 24 weeks, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorg Kempfert, MD
Organizational Affiliation
German Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Hertzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34010408
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.
Results Reference
background
PubMed Identifier
32673661
Citation
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.
Results Reference
background
PubMed Identifier
31254509
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.
Results Reference
background
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DARTS I: Feasibility, Safety, and Performance Trial
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