Thoraflex™ Hybrid IDE Study
Public ClinicalTrials.gov record NCT02724072. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02724072
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 84 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 22, 2016 (Actual)
- Primary completion
- Jun 24, 2019 (Actual)
- Completion
- Jul 30, 2021 (Actual)
- Last update posted
- May 16, 2022
2016 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94305-5407 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-5853 | — |
| The Mount Sinai Hospital | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| NY Presbyterian Weill Cornell | New York | New York | 10065 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 10104 | — |
| University of Pittsburgh Medical Center (UPMC) Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| Baylor St. Luke's | Houston | Texas | 77030 | — |
| University of Texas Houston- Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02724072, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2022 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02724072 live on ClinicalTrials.gov.