DARTS I: Feasibility, Safety, and Performance Trial

NCT03397251 | Completed DMC

• 1 other identifier: DARTS-AMDS
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute DeBakey I Aortic Dissection; Intramural Hematoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Number of participants with treatment-related mortality

  24 weeks and 12 months

• Number of participants with treatment-related neurological deficit

  24 weeks and 12 months

• Number of patients with aortic injury associated with the implantation of the device

  24 weeks and 12 months

• Aortic arch branch vessel patency

  24 weeks and 12 months

Other Outcomes (12)

• Re-expansion of the true lumen

  12 weeks, 24 weeks, and 12 months

• False lumen reattachment/positive remodeling

  12 weeks, 24 weeks, and 12 months

• False Lumen Thrombosis

  12 weeks, 24 weeks, and 12 months

Study Arms (1)

AMDS Implantation

EXPERIMENTAL

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

Device: AMDS

Interventions

AMDS DEVICE

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.

AMDS Implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent obtained
• ≥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:
• Acute DeBakey I dissection or
• Acute DeBakey I intramural hematoma (IMH)

You may not qualify if:

• 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
• Refusal to give informed consent
• Institutionalized individualized due to administrative or judicial order
• Individuals with a dependent relationship to the sponsor or investigator
• 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

Sponsors & Collaborators

• Ascyrus Medical LLC.: lead
• Artivion Inc.: collaborator

Study Sites (1)

Deutsches Hertzzentrum Berlin

Berlin, 13353, Germany

Location

Related Publications (3)

• 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.

  PMID: 34010408 BACKGROUND

• 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.

  PMID: 32673661 BACKGROUND

• 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.

  PMID: 31254509 BACKGROUND

Study Officials

• Jorg Kempfert, MD

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of the AMDS

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: January 11, 2018
• Study Start: March 7, 2018
• Primary Completion: September 26, 2018
• Study Completion: January 23, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)