Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03894033 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection

Study acronym: PROTECT
StatusActive, Not Recruiting
PhaseNot specified
SponsorJOTEC GmbH
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 9, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 31, 2025 to Jun 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 300 to confirmed 301
    • Site details revised
    v7
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Jun 30, 2029 to Jun 30, 2030
    • Site details revised
    v6
  3. Lead sponsor: Ascyrus Medical LLC. to JOTEC GmbHv5 Show 9 more changesShow less
    • Enrollment target: 100 to 300
    • Primary completion date: Jun 15, 2021 to Dec 31, 2024
    • Primary endpoints: 5 to 1
    • Study sites: 3 to 1
    • Study completion date: Feb 15, 2024 to Jun 30, 2029
    • Secondary endpoints: 6 to 29
    • Study description shortened, about 127 words
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 4 words
  4. Primary completion date: Jun 15, 2020 to Jun 15, 2021v4
  5. Study sites: 1 to 3v3
  6. Primary endpoints revised (5)
    • Secondary endpoints revised (6)
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
JOTEC GmbH
14 trials monitored
See 1 trial at risk
The objective of this registry is to collect information on the performance and clinical benefits of the AMDS (Ascyrus Medical Dissection Stent) to treat patients with acute "DeBakey type I dissections" and with or without so called "preoperative clinically relevant malperfusion" and/or "intramural hematomas". In a healthy aorta (the vessel that supplies blood to most of the body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). The participants involved in this study have a tear that has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen), and huts, the blood flows through both channels. AMDS is a stent (a metal tube helping to keep the vessel open) that is placed in the descending thoracic aorta. AMDS is a medical device commercially available in the countries in which the study is being conducted and it is used as standard of care according to its indication.
Trial Details
NCT Number NCT03894033
Lead Sponsor JOTEC GmbH
Conditions
(from sponsor)		 Aortic Dissection, Acute DeBakey I Dissection, Acute Type A Dissection, Intramural Hematoma
Related terms Aortic Diseases, Aortic Dissection, Cardiovascular Diseases
Enrollment 301 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov