CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Orbital Atherectomy System (OAS) +2 moredevice
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.

Search/NCT03021577
NCT03021577N/ACompleted
CompareCT.gov

Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in Percutaneous Coronary Intervention (PCI)

Columbia University·interventional·Posted Jan 16, 2017·Updated Aug 6, 2025

In Brief

A clinical study evaluating Orbital Atherectomy System (OAS), Rotablator Rotational Atherectomy System, and 1 other intervention for Coronary Artery Disease (CAD). Completed, enrolled 37 participants across 1 site.

Detailed Summary

The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation atherectomy device, reduces the incidence of microcirculatory compromise as compared to older generation rotational atherectomy (RA) due to differences in the mechanism of athero-ablation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease (CAD)
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 16, 2017
Enrollment StartJan 25, 2017
Primary CompletionMar 16, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.5 years ago

Interventions

Orbital Atherectomy System (OAS)device

The Cardiovascular Systems, Inc. (CSI) Diamondback 360 Coronary Orbital Atherectomy System (OAS) is a catheter-based system designed for facilitating stent delivery in patients with coronary artery lesions. The OAS consists of the hand-held CSI DIAMONDBACK 360 Coronary Orbital Atherectomy Device (OAD), the CSI Saline Infusion Pump (OAS pump), the CSI ViperWire Advance Coronary Guide Wire (VIPERWIRE guide wire), and the CSI ViperSlide Lubricant.

Rotablator Rotational Atherectomy Systemdevice

The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console

Magnetic Resonance Imaging (MRI)procedure

In a subset of patients (n= 20) a baseline cardiac MRI will be performed prior to PCI and repeated 24 hours after PCI to quantify the total volume of myocardial necrosis secondary to PCI.