DARTS I Feasibility Study

Aortic Dissection Clinical Trial

— DARTS I  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03035643
• Other study ID #: Pro00066039_AME3
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2017
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: Artivion Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aortic Dissection
• Hematoma
• Intramural Hematoma

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ascyrus Medical LLC.	Artivion Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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

Outcome

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