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NCT00646048 · ClinicalTrials.gov registry record · Phase 1
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
A Phase 1 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT00646048: Completed Phase 1 study, sponsored by Boston Scientific Corporation.
NCT00646048 is a Phase 1 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00646048, a Phase 1 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.
Primary Outcome
Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.
Interventions
- DEVICE TriVascular Stent-Graft System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2003-02 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
What the finished NCT00646048 record still lists
NCT00646048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 1 intervention - of which TriVascular Stent-Graft System is the first listed.
NCT00646048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00646048 about?
NCT00646048 is a clinical study titled "A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms". This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to de...
What is the current status of trial NCT00646048?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2003-02. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00646048?
The interventions under investigation include: TriVascular Stent-Graft System (DEVICE).
Who is sponsoring clinical trial NCT00646048?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00646048's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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