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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.

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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

FieldValue
Enrollment Target 84 participants
Start Date 2016-08-22
Est. Completion 2021-07-30
Phase NA

Sponsor

Bolton Medical

10 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.