DARTS I: Feasibility, Safety, and Performance Trial

Not Applicable

Completed

• Conditions: Acute DeBakey I Aortic Dissection; Intramural Hematoma
• Interventions: Device: AMDS

• Registration Number: NCT03397251
• 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, 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 Timeline

• Study First Submitted: 2018-01-06
• Study First Submitted QC: 2018-01-06
• Study First Posted: 2018-01-11
• Study Start: 2018-03-07
• Primary Completion: 2018-09-26
• Study Completion: 2024-01-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Informed Consent obtained

2. ≥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:

3. Acute DeBakey I dissection or

4. 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:

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
6. Institutionalized individualized due to administrative or judicial order
7. 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:

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
7. Aortic arch aneurysm > 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 treatment-related neurological deficit	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	12 weeks	The number of patients with aortic injury related to the treatment device
Number of participants with treatment-related mortality	12 weeks	The number of patients with mortality related to the treatment device
Aortic arch branch vessel patency	12 weeks	The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related mortality	24 weeks and 12 months	The number of patients with mortality related to the device and procedure
Number of patients with aortic injury associated with the implantation of the device	24 weeks and 12 months	The number of patients with aortic injury related to the treatment device
Number of participants with treatment-related neurological deficit	24 weeks and 12 months	The number of patients with neurological complications, such as stroke, TIA, and paralysis/paraplegia) related to the treatment device
Aortic arch branch vessel patency	24 weeks and 12 months	The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device

Trial Locations

Locations (1)

Deutsches Hertzzentrum Berlin; 🇩🇪 Berlin, Germany