DARTS I Feasibility Study

Not Applicable

Completed

• Conditions: Intramural Hematoma; Aortic Dissection
• Interventions: Device: AMDS

• Registration Number: NCT03035643
• Lead Sponsor: Ascyrus Medical LLC.

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 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.

Study Timeline

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Study Start: 2017-03-05
• Primary Completion: 2019-08-21
• Study Completion: 2024-03-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMDS Implantation	AMDS	AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.

Primary Outcome Measures

Name	Time	Method
Number of participants with neurological complications (TIA, stroke)	Late (6 months)	The number of patients with neurological complications related to the treatment device
Number of participants with device-related mortality	Late (6 months)	The number of patients with mortality related to the treatment device

Secondary Outcome Measures

Name	Time	Method
Successful reattachment of the intimal flap within the arch	Annually, through study completion, an average of 5 years	The number of patients that has successful reattachment of the intimal flap within the arch following the implantation of AMDS
Thrombosis of the false lumen within the confines of the device	Annually, through study completion, an average of 5 years	Efficacy outcome: Number of participants with false lumen exclusion within the treatment area confined by the treatment device.
Assess need for stent removal	Annually, through study completion, an average of 5 years	Stent placement and retention. The number of patients requiring removal of the stent.
Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device	Annually, through study completion, an average of 5 years	The number of patients which has successful AMDS deployment and which also had radiographic evidence of false lumen exclusion within the confines of AMDS

Trial Locations

Locations (5)

London Health Sciences Center- University Hospital; 🇨🇦 London, Ontario, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Mazankowski Alberta Heart Institute, University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada

Centre Hospitalier de I'Universite de Montreal (CHUM); 🇨🇦 Montréal, Quebec, Canada