NCT03397251 (DARTS I) is a NA clinical trial of AMDS in Acute DeBakey I Aortic Dissection, sponsored by Ascyrus Medical LLC..

Who is sponsoring NCT03397251?

NCT03397251 is sponsored by Ascyrus Medical LLC..

What drugs are being tested in NCT03397251?

Interventions in NCT03397251: AMDS.

What condition does NCT03397251 study?

NCT03397251 studies Acute DeBakey I Aortic Dissection, Intramural Hematoma.

Is NCT03397251 still recruiting?

NCT03397251 is currently completed. Last updated 20 August 2024.

Last reviewed 2024-08-20 · How we verify

NCT03397251: DARTS I

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

DARTS I: Feasibility, Safety, and Performance Trial

Completed NA Last updated 20 August 2024

What this trial tests

NA trial testing AMDS in Acute DeBakey I Aortic Dissection in 7 participants. Completed in 23 January 2024.

Timeline

7 March 2018

Primary endpoint
26 September 2018

23 January 2024

Quick facts

Lead sponsor	Ascyrus Medical LLC.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	7 March 2018
Primary completion	26 September 2018
Estimated completion	23 January 2024
Sites	1 location across Germany

Drugs / interventions tested

AMDS

Conditions studied

Acute DeBakey I Aortic Dissection — all drugs for Acute DeBakey I Aortic Dissection →
Intramural Hematoma — all drugs for Intramural Hematoma →

Sponsor

Ascyrus Medical LLC.

Who can join

Adults 18 to 80, any sex, with Acute DeBakey I Aortic Dissection or Intramural Hematoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of AMDS

Trials testing the same drug.

NCT05174767 — PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection · NA · active not recruiting
NCT03035643 — DARTS I Feasibility Study · NA · completed

Other Ascyrus Medical LLC. trials

Trials by the same sponsor.

NCT03035643 — DARTS I Feasibility Study · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03397251 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ascyrus Medical LLC.
Last refreshed: 20 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03397251.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing