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NCT01930214 · ClinicalTrials.gov registry record
Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 350
- Enrollment target
NCT01930214: Completed study, sponsored by Abbott Medical Devices.
NCT01930214 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 350 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01930214 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 350 participants
- Enrollment target
Study Summary
The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using: * A composite of MACE at 30-day and one (1) year post procedure, and * Procedural and lesion success
Primary Outcome
A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 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
Interventions
- DEVICE Percutaneous Coronary Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2013-09-26 |
| Est. Completion | 2017-06-01 |
What the finished NCT01930214 record still lists
NCT01930214 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Percutaneous Coronary Intervention is the first listed.
NCT01930214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01930214 about?
NCT01930214 is a clinical study titled "Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)". The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using: * A composite of MACE at 30-day and one (1) year post procedure, and * Procedural and lesion success
What is the current status of trial NCT01930214?
This trial is currently completed. The enrollment target is 350 participants. The study started on 2013-09-26. Estimated completion is 2017-06-01.
What interventions are being tested in trial NCT01930214?
The interventions under investigation include: Percutaneous Coronary Intervention (DEVICE).
Who is sponsoring clinical trial NCT01930214?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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