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NCT02132611 · ClinicalTrials.gov registry record · NA
Coronary Orbital Atherectomy System Study
A NA study of CAD, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 17
- Study locations
NCT02132611: Completed NA study of CAD, sponsored by Abbott Medical Devices.
NCT02132611 is a NA study of CAD that has completed, run by Abbott Medical Devices. The registered enrollment target is 100 participants, below the 2,020-participant average among 4 other CAD trials with a reported enrollment target (95% lower). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02132611, a NA study of CAD, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of the COAST clinical study data will be to utilize and to gain approval for commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).
Primary Outcome
A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days. 30-Day MACE is composed of: * Cardiac death * Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave * Target Vessel Revascularization (TVR) - defined as a revascularization at the target vess
Conditions Studied
Interventions
- DEVICE Diamondback 360® Coronary OAS Micro Crown
Study Locations (17)
Florida
- North Florida Regional Medical Center - Gainesville
- Palm Beach Gardens - Jupiter
- Munroe Regional Health System, Inc. - Ocala
- Florida Hospital - Orlando
- Tallahassee Research Institute - Tallahassee
New York
- Mount Sinai Hospital New York - New York
- Columbia University Medical Center - New York
- St. Francis Hospital - Roslyn
North Carolina
- Duke University - Durham
- NC Heart and Vascular Research - Raleigh
Kanagawa
- Shonan Kamakura General Hospital - Kamakura
- Saiseikai Yokohamashi Tobu Hospital - Yokohama
Arizona
- Chandler Regional Medical Center and Mercy Gilbert Medical Center - Chandler
Mississippi
- Baptist Memorial Hospital/Stern Cardiovascular Foundation, Inc. - Southaven
Hokkaido
- Sapporo Higashi Tokushukai Hospital - Sapporo
Miyazaki
- Miyazaki Medical Association Hospital - Miyazaki
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-06 |
| Est. Completion | 2017-06 |
| Phase | NA |
What the finished NCT02132611 record still lists
NCT02132611 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,020-participant average among 4 other CAD trials with a reported enrollment target (95% lower).
The record links to 1 condition, with CAD appearing as the primary indexed condition, and to 1 intervention - of which Diamondback 360® Coronary OAS Micro Crown is the first listed.
NCT02132611 lists 17 locations in 9 states (Florida, New York, North Carolina).
Frequently Asked Questions
What is clinical trial NCT02132611 about?
NCT02132611 is a clinical study titled "Coronary Orbital Atherectomy System Study". The purpose of the COAST clinical study data will be to utilize and to gain approval for commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).
What is the current status of trial NCT02132611?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2014-06. Estimated completion is 2017-06.
What conditions does trial NCT02132611 study?
This clinical trial studies the following conditions: CAD.
What interventions are being tested in trial NCT02132611?
The interventions under investigation include: Diamondback 360® Coronary OAS Micro Crown (DEVICE).
Who is sponsoring clinical trial NCT02132611?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02132611 being conducted?
This trial has 17 study locations across Arizona, Florida, Mississippi, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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