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PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection

  • Status
    Accepting Candidates
  • Age
    18 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open surgical repair.

Details

Full study title A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE
Protocol number OCR41668
ClinicalTrials.gov ID NCT05174767
Phase N/A

Eligibility

Inclusion Criteria:

  • ≥18 years of age or ≤80 years of age (male or female) at time of surgery

  • Acute DeBakey type I dissection based on computed tomography angiography (CTA) and diagnosed ≤14 days from of the index event

  • Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)

Exclusion Criteria:

  • Other medical condition that is associated with limited life expectancy 45 mm in diameter

  • Aortic arch aneurysm >50 mm in diameter

Lead researcher

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  4. Step
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