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NCT02724072 · ClinicalTrials.gov registry record · NA
Thoraflex™ Hybrid IDE Study
A NA study, sponsored by Bolton Medical.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
NCT02724072 is a NA study that has completed, run by Bolton Medical. The registered enrollment target is 84 participants.
The verdict
NCT02724072, a NA study, has completed, sponsored by Bolton Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
Study Summary
The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta. The study will also assess safety and early clinical outcomes in patients who receive an extension procedure within 1 year of Thoraflex™ Hybrid Device implantation. Lastly the study will assess the safety and clinical outcomes of patients who receive a Thoraflex™ Hybrid Device for treatment of a ruptured aorta. Patients will be followed for 3 years. The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1 year post-procedure.
Interventions
- DEVICE Thoraflex™ Hybrid Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2016-08-22 |
| Est. Completion | 2021-07-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02724072
The ClinicalTrials.gov registry entry for NCT02724072 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bolton Medical, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Thoraflex™ Hybrid Device is the first listed.
NCT02724072 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02724072 about?
NCT02724072 is a clinical study titled "Thoraflex™ Hybrid IDE Study". The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta. The study will also assess safety and early clinical ...
What is the current status of trial NCT02724072?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2016-08-22. Estimated completion is 2021-07-30.
What interventions are being tested in trial NCT02724072?
The interventions under investigation include: Thoraflex™ Hybrid Device (DEVICE).
Who is sponsoring clinical trial NCT02724072?
This trial is sponsored by Bolton Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
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