Trials / Active Not Recruiting
Active Not RecruitingNCT05174767
PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Artivion Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AMDS | AMDS Implantation |
Timeline
- Start date
- 2022-05-27
- Primary completion
- 2023-12-11
- Completion
- 2029-12-06
- First posted
- 2022-01-03
- Last updated
- 2025-01-15
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05174767. Inclusion in this directory is not an endorsement.