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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: Completed NA study, sponsored by Bolton Medical.
NCT02724072 is a NA study that has completed, run by Bolton Medical. The registered enrollment target is 84 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Freedom from the following composite Major Adverse Events (MAE) occurring ≤ 1 year post-procedure: * Permanent stroke * Permanent paraplegia/paraparesis * Unanticipated aortic-related re-operation (excluding re-operation for bleeding) * All-cause mortality All relevant events will be adjudicated by CEC. Data will be analysed and presented in a binary format (i.e. Freedom from the listed AE's - Yes/No).
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 |
What the finished NCT02724072 record still lists
NCT02724072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Thoraflex™ Hybrid Device is the first listed.
NCT02724072 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02724072's enrollment target sits among peer trials
84 983rd of 2000 higher than 1,011 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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