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Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in PCI

NCT03021577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-08-06

Study results available
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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.

Conditions

  • Coronary Artery Disease (CAD)

Interventions

DEVICE

Orbital Atherectomy System (OAS)

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.

DEVICE

Rotablator Rotational Atherectomy System

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

PROCEDURE

Magnetic Resonance Imaging (MRI)

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.

Sponsors & Collaborators

Principal Investigators

  • Ziad A. Ali, MD · Columbia University

  • Jeffrey W. Moses, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-25
Primary Completion
2019-03-16
Completion
2019-03-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021577 on ClinicalTrials.gov