At a glance
ClinicalIndex Comparison RecordN/ACompleted· 350 enrolled
Drug / intervention
Percutaneous Coronary Interventiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
In Brief
An observational study evaluating Percutaneous Coronary Intervention for Coronary Artery Disease. Completed, enrolled 350 participants across 34 sites.
Detailed 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
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartSep 2013
Primary CompletionNov 2016
Study CompletionJun 2017
TodayJul 2026
First PostedAug 28, 2013
Enrollment StartSep 26, 2013
Primary CompletionNov 7, 2016
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.8 years ago
Interventions
Percutaneous Coronary Interventiondevice
Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).