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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: Completed NA study, sponsored by Bolton Medical.
NCT00435942 is a NA study that has completed, run by Bolton Medical. The registered enrollment target is 180 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary effectiveness endpoint was freedom from major device-related adverse events \[endoleak (Types I, III and IV), stent migration (\> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair\] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (n
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 |
What the finished NCT00435942 record still lists
NCT00435942 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Relay Thoracic Stent-Graft is the first listed.
NCT00435942 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00435942's enrollment target sits among peer trials
180 586th of 2000 higher than 1,397 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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