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DARTS I: Feasibility, Safety, and Performance Trial

NCT03397251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-08-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Artivion Inc.

    collaborator INDUSTRY

  • Ascyrus Medical LLC.

    lead INDUSTRY

Principal Investigators

  • Jorg Kempfert, MD · German Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2018-09-26
Completion
2024-01-23

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397251 on ClinicalTrials.gov