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NCT00676520 · ClinicalTrials.gov registry record
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 8,053
- Enrollment target
NCT00676520: Completed study, sponsored by Abbott Medical Devices.
NCT00676520 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 8,053 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00676520 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 8,053 participants
- Enrollment target
Study Summary
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are * To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and * To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.
Primary Outcome
ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory o
Interventions
- DEVICE XIENCE V® Everolimus Eluting Coronary Stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,053 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-03 |
What the finished NCT00676520 record still lists
NCT00676520 is an observational study that tracks outcomes without assigning an intervention. Its 8,053 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which XIENCE V® Everolimus Eluting Coronary Stent is the first listed.
NCT00676520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00676520 about?
NCT00676520 is a clinical study titled "XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)". XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are * To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and * To support the Food and Drug Administration (FDA) dual antiplatelet the...
What is the current status of trial NCT00676520?
This trial is currently completed. The enrollment target is 8,053 participants. The study started on 2008-07. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00676520?
The interventions under investigation include: XIENCE V® Everolimus Eluting Coronary Stent (DEVICE).
Who is sponsoring clinical trial NCT00676520?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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