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NCT00530504 · ClinicalTrials.gov registry record · NA
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
A NA study of Carotid Artery Disease, sponsored by Medtronic Endovascular.
- Completed
- Registry status
- NA
- Development phase
- 1,500
- Enrollment target
- 2
- Study locations
NCT00530504: Completed NA study of Carotid Artery Disease, sponsored by Medtronic Endovascular.
NCT00530504 is a NA study of Carotid Artery Disease that has completed, run by Medtronic Endovascular. The registered enrollment target is 1,500 participants, below the 13,433-participant average among 5 other Carotid Artery Disease trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00530504, a NA study of Carotid Artery Disease, has completed, sponsored by Medtronic Endovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,500 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purposes of this study are: 1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device. 2. To evaluate rare and unanticipated adverse events. 3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.
Primary Outcome
Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.
Conditions Studied
Interventions
- DEVICE PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device
Study Locations (2)
New York
- Stony Brook University Hospital - Stony Brook
Tennessee
- Wellmont Medical Center - Kingsport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2007-05 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT00530504 record still lists
NCT00530504 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 13,433-participant average among 5 other Carotid Artery Disease trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Carotid Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device is the first listed.
NCT00530504 reports a single indexed study location in New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT00530504 about?
NCT00530504 is a clinical study titled "Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study". The purposes of this study are: 1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device. 2. To evaluate rare and unanticipated adverse events. 3. To evaluate the physician ...
What is the current status of trial NCT00530504?
This trial is currently completed. It is a NA study. The enrollment target is 1,500 participants. The study started on 2007-05. Estimated completion is 2014-01.
What conditions does trial NCT00530504 study?
This clinical trial studies the following conditions: Carotid Artery Disease.
What interventions are being tested in trial NCT00530504?
The interventions under investigation include: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device (DEVICE).
Who is sponsoring clinical trial NCT00530504?
This trial is sponsored by Medtronic Endovascular, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00530504 being conducted?
This trial has 2 study locations across New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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