Aortic DissectionDARTS INCT03035643

DARTS I Feasibility Study

A study testing AMDS in people with Aortic Dissection and Intramural Hematoma, run by Ascyrus Medical LLC. at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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: 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: 40 participants
Where: 5 sitesCanada
Study dates: 5 Mar 2017to 19 Mar 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

Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:
Acute DeBakey type I dissection or
Acute DeBakey type 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 22Show fewer

Refusal to give informed consent
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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Canada5 sites

Mazankowski Alberta Heart Institute, University of Alberta
Edmonton, Alberta, T6G 2B7
London Health Sciences Center- University Hospital
London, Ontario, N6A 5A5
Montreal Heart Institute
Montreal, Quebec, HIT 1C8
Centre Hospitalier de I'Universite de Montreal (CHUM)
Montreal, Quebec
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study

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 study 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 40 subjects will be enrolled at approximately 5 sites in Canada.

The enrollment period will span a minimum of 12 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.

Conditions: Aortic Dissection, Intramural Hematoma
Being tested: AMDS
Medical subject headings: Aortic Dissection

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 groups in NCT03035643
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 device-related mortality
The number of patients with mortality related to the treatment device
Measured: Early (within 30 days)
Number of participants with device-related mortality
The number of patients with mortality related to the treatment device
Measured: Intermediate (3 months)
Number of participants with device-related mortality
The number of patients with mortality related to the treatment device
Measured: Late (6 months)
Number of participants with neurological complications (TIA, stroke)
The number of patients with neurological complications related to the treatment device
Measured: Early (within 30 days)
Number of participants with neurological complications (TIA, stroke)
The number of patients with neurological complications related to the treatment device
Measured: Intermediate (3 months)
Number of participants with neurological complications (TIA, stroke)
The number of patients with neurological complications related to the treatment device
Measured: Late (6 months)

Secondary outcomes (4)

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.
Measured: Annually, through study completion, an average of 5 years
Assess need for stent removal
Stent placement and retention. The number of patients requiring removal of the stent.
Measured: Annually, through study completion, an average of 5 years
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
Measured: Annually, through study completion, an average of 5 years
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
Measured: Annually, through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 201719 Mar 2024

First posted30 Jan 2017 (estimated)
Study start5 Mar 2017
Primary completion21 Aug 2019
Study completion19 Mar 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 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 AMDS
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03035643
Sponsor's protocol ID: Pro00066039_AME3
Acronym: DARTS I
Status last verified: Aug 2024
First submitted: 20 Jan 2017
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

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.
PubMed 32673661
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.
PubMed 30501947
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.
PubMed 31254509
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 34010408

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection

All Aortic Dissection trials

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 Study
ClinicalTrials.gov ID: NCT03035643
Acronym / sponsor ID: DARTS I / Pro00066039_AME3
Conditions: Aortic Dissection, Intramural Hematoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Ascyrus Medical LLC.Industry (pharma, biotech, devices)
Collaborators: Artivion Inc.
Study start: 5 Mar 2017 (actual)
Primary completion: 21 Aug 2019 (actual)
Study completion: 19 Mar 2024 (actual)
First posted: 30 Jan 2017 (estimated)
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.

Detailed description

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 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 (3 listed)

Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:
Acute DeBakey type I dissection or
Acute DeBakey type I intramural hematoma (IMH)

Key exclusion criteria (22 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 device-related mortality
Time frame: Early (within 30 days)
The number of patients with mortality related to the treatment device
Number of participants with device-related mortality
Time frame: Intermediate (3 months)
The number of patients with mortality related to the treatment device
Number of participants with device-related mortality
Time frame: Late (6 months)
The number of patients with mortality related to the treatment device
Number of participants with neurological complications (TIA, stroke)
Time frame: Early (within 30 days)
The number of patients with neurological complications related to the treatment device
Number of participants with neurological complications (TIA, stroke)
Time frame: Intermediate (3 months)
The number of patients with neurological complications related to the treatment device
Number of participants with neurological complications (TIA, stroke)
Time frame: Late (6 months)
The number of patients with neurological complications related to the treatment device

4 secondary outcomes

Thrombosis of the false lumen within the confines of the device
Time frame: Annually, through study completion, an average of 5 years
Assess need for stent removal
Time frame: Annually, through study completion, an average of 5 years
Successful reattachment of the intimal flap within the arch
Time frame: Annually, through study completion, an average of 5 years
Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device
Time frame: Annually, through study completion, an average of 5 years

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 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 30501947Bozso 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.
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.
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.
Individual participant dataSharing planned: No

Related trials for Aortic Dissection

Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection

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.

Jessica Forcillo, MD principal investigator

Centre Hospitalier de I'Universite de Montreal

Maral Ouzounian, MD principal investigator

University Health Network - Toronto General Hospital

Michael Chu, MD principal investigator

London Health Science Center

5 sites 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 Aortic Dissection and Intramural Hematoma, run by Ascyrus Medical LLC. at 5 sites in Canada.

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 3 inclusion and 22 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 5 sites in Canada. 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 device-related mortality (time frame: Early (within 30 days)). The study lists 6 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 NCT03035643, 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; AzTrials last refreshed its copy on 27 Oct 2026.