DARTS I: Feasibility, Safety, and Performance Trial (DARTS I)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intramural Hematoma; Acute DeBakey I Aortic Dissection
• Intervention / Treatment: Device: AMDS

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Deutsches Hertzzentrum Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMDS Implantation; AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related mortality	The number of patients with mortality related to the treatment device	12 weeks
Number of participants with treatment-related neurological deficit	The number of patients with neurological complications related to the treatment device	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	12 weeks
Aortic arch branch vessel patency	The number of patients with arch branch vessel stenosis/ occlusion related to the treatment device	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related mortality	The number of patients with mortality related to the device and procedure	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	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	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	24 weeks and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-expansion of the true lumen	The number of patients with achieved re-expansion of the true lumen following AMDS implantation	12 weeks, 24 weeks, and 12 months
False lumen reattachment/positive remodeling	The number of patients which exhibit positive remodeling/false lumen reattachment as measured by CT.	12 weeks, 24 weeks, and 12 months
False Lumen Thrombosis	The percentage of patients with evidence of false lumen thrombosis within the confinement of the AMDS, distal to the AMDS but proximal to the Celiac trunk, along the paravisceral aorta and in the infrarenal aorta.	12 weeks, 24 weeks, and 12 months
Stent-graft integrity Assessment	The percentage of patients without evidence of stent-graft fractures, kinking, or twisting leading to occlusion or ischemia in patients that have undergone aortic dissection repair with AMDS. Stent graft integrity will be evaluated by CTA with a Core Imaging Lab.	12 weeks, 24 weeks, and 12 months
Successful device deployment	The number of patients which had successful device deployment	12 weeks, 24 weeks, and 12 months
AMDS removal	The percentage of patients that required AMDS removal	12 weeks, 24 weeks, and 12 months
AMDS related re-interventions after the dissection repair	The percentage of patients with need of secondary intervention related to the AMDS implantation following the index procedure for aortic dissection repair	12 weeks, 24 weeks, and 12 months
Cardiopulmonary bypass (CBP) duration	The total time (in minutes) of CBP required for patients undergoing AMDS implantation	12 weeks, 24 weeks, and 12 months
Circulatory arrest duration	The total time (in minutes) of circulatory arrest for patients undergoing AMDS implantation	12 weeks, 24 weeks, and 12 months
Time in ICU	The total amount of days for patients that have undergo aortic dissection repair with AMDS implantation	12 weeks, 24 weeks, and 12 months
Duration of hospitalization	The total number of days of hospitalization required for patients undergoing AMDS implantation	12 weeks, 24 weeks, and 12 months
AMDS procedure duration	The total amount of time (in minutes) that it takes for AMDS to be implanted	12 weeks, 24 weeks, and 12 months

Collaborators and Investigators

• Sponsor: Ascyrus Medical LLC.
• Collaborators: Artivion Inc.
• Investigators: Principal Investigator: Jorg Kempfert, MD, German Heart Institute

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): September 26, 2018
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: January 6, 2018
• First Submitted That Met QC Criteria: January 6, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hemorrhage; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Hematoma; Aortic Dissection
• Other Study ID Numbers: DARTS-AMDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes