Acute DeBakey I Aortic DissectionDARTS INCT03397251
DARTS I: Feasibility, Safety, and Performance Trial
A study testing AMDS in people with Acute DeBakey I Aortic Dissection and Intramural Hematoma, run by Ascyrus Medical LLC. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute DeBakey I Aortic Dissection, Intramural Hematoma
- What is being tested?
- AMDS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- 7 Mar 2018to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial
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.
Read the 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.
- Being tested
- AMDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMDSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AMDS Implantation | Experimental | AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair. Receives: Device: AMDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related mortality
The number of patients with mortality related to the treatment device
Measured: 12 weeks
Number of participants with treatment-related neurological deficit
The number of patients with neurological complications related to the treatment device
Measured: 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
Measured: 12 weeks
Aortic arch branch vessel patency
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
Measured: 12 weeks
Secondary outcomes (4)
Number of participants with treatment-related mortality
The number of patients with mortality related to the device and procedure
Measured: 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
Measured: 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
Measured: 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
Measured: 24 weeks and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start7 Mar 2018
- Primary completion26 Sep 2018
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute DeBakey I Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of the AMDS
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascyrus Medical LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artivion Inc.
- Responsible party
- Sponsor
- Investigators
- Jorg Kempfert, MD, Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397251
- Sponsor's protocol ID
- DARTS-AMDS
- Acronym
- DARTS I
- Status last verified
- Aug 2024
- First submitted
- 6 Jan 2018
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34010408Bozso 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.
PubMed 32673661Bozso 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.
PubMed 31254509Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Forcillo J, Kempfert J, Starck C, Moon MC. Three-year outcomes of the Dissected Aorta Repair Through Stent Implantation trial. J Thorac Cardiovasc Surg. 2024 May;167(5):1661-1669.e3. doi: 10.1016/j.jtcvs.2022.08.040. Epub 2022 Sep 11.
PubMed 36220703
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility, Safety and Performance Trial
- ClinicalTrials.gov ID
- NCT03397251
- Acronym / sponsor ID
- DARTS I / DARTS-AMDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ascyrus Medical LLC.Industry (pharma, biotech, devices)
- Collaborators
- Artivion Inc.
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of the AMDS
| Arm | Type | Receives |
|---|---|---|
| AMDS Implantation | Experimental | Device: AMDSAMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (25 listed)
- General Exclusion Criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMDSThe 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. | Device | AMDS Implantation |
Primary outcome
Number of participants with treatment-related mortality
Time frame: 12 weeks
The number of patients with mortality related to the treatment device
Number of participants with treatment-related neurological deficit
Time frame: 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
Time frame: 12 weeks
The number of patients with aortic injury related to the treatment device
Aortic arch branch vessel patency
Time frame: 12 weeks
The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device
4 secondary outcomes
Number of participants with treatment-related mortality
Time frame: 24 weeks and 12 months
Number of participants with treatment-related neurological deficit
Time frame: 24 weeks and 12 months
Number of patients with aortic injury associated with the implantation of the device
Time frame: 24 weeks and 12 months
Aortic arch branch vessel patency
Time frame: 24 weeks and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 34010408Montagner 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.
- Background: PubMed 32673661Bozso 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.
- Background: PubMed 31254509Bozso 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.
- Derived from this study: PubMed 36220703Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Forcillo J, Kempfert J, Starck C, Moon MC. Three-year outcomes of the Dissected Aorta Repair Through Stent Implantation trial. J Thorac Cardiovasc Surg. 2024 May;167(5):1661-1669.e3. doi: 10.1016/j.jtcvs.2022.08.040. Epub 2022 Sep 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorg Kempfert, MD principal investigator
German Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMDS in people with Acute DeBakey I Aortic Dissection and Intramural Hematoma, run by Ascyrus Medical LLC. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related mortality (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397251, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.