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NCT00435942 · ClinicalTrials.gov registry record · NA
Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
A NA study, sponsored by Bolton Medical.
- Completed
- Registry status
- NA
- Development phase
- 180
- Enrollment target
NCT00435942 is a NA study that has completed, run by Bolton Medical. The registered enrollment target is 180 participants.
The verdict
NCT00435942, a NA study, has completed, sponsored by Bolton Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.
Interventions
- DEVICE Relay Thoracic Stent-Graft
- PROCEDURE Open Repair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2007-01 |
| Est. Completion | 2017-05-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00435942
The ClinicalTrials.gov registry entry for NCT00435942 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 180 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 2 interventions - of which Relay Thoracic Stent-Graft is the first listed.
NCT00435942 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00435942 about?
NCT00435942 is a clinical study titled "Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft". The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be eva...
What is the current status of trial NCT00435942?
This trial is currently completed. It is a NA study. The enrollment target is 180 participants. The study started on 2007-01. Estimated completion is 2017-05-15.
What interventions are being tested in trial NCT00435942?
The interventions under investigation include: Relay Thoracic Stent-Graft (DEVICE), Open Repair (PROCEDURE).
Who is sponsoring clinical trial NCT00435942?
This trial is sponsored by Bolton Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
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