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

NCT03021577 | Completed Results FDA Device

• 1 other identifier: AAAQ9267
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

orbital atherectomy system; rotational atherectomy; Fractional flow reserve; coronary flow reserve; index of microcirculatory resistance (IMR)

Outcome Measures

Primary Outcomes (3)

• Index of Microcirculatory Resistance (IMR)

  Index of Microvascular Resistance (IMR) is defined as the distal coronary pressure multiplied by the hyperaemic mean transit time. IMR = Pd x Tmn at maximal hyperemia. This is for micro vascular function.

  Up to 1 hour

• Fractional Flow Reserve (FFR)

  FFR is defined as the ratio of (i.e., percent of normal) flow in the stenotic artery to the flow in the same artery in the theoretic absence of the stenosis.

  Up to 1 hour

• Coronary Flow Reserve (CFR)

  Coronary Flow Reserve (CFR) is the ratio between hyperemic and basal coronary flow. CFR=Hyperemic Flow /Resting Flow. This is for micro vascular function.

  Up to 1 hour

Other Outcomes (2)

• Troponin I Level

  1 hour

• Creatinine Kinase (CKMB) Level

  1 hour

Study Arms (2)

Orbital Atherectomy System (OAS) Group

ACTIVE COMPARATOR

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

Device: Orbital Atherectomy System (OAS); Procedure: Magnetic Resonance Imaging (MRI)

Rotational Atherectomy (RA) Group

ACTIVE COMPARATOR

Subjects randomized to RA using the Rotablator Rotational Atherectomy System. In a subset of patients (n= 20) a baseline cardiac magnetic Resonance Imaging (MRI) scan will be performed prior to PCI and repeated 24 hours after PCI to quantify the total volume of myocardial necrosis secondary to PCI.

Device: Rotablator Rotational Atherectomy System; Procedure: Magnetic Resonance Imaging (MRI)

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.

Orbital Atherectomy System (OAS) Group

Rotablator Rotational Atherectomy System DEVICE

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

Rotational Atherectomy (RA) Group

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.

Orbital Atherectomy System (OAS) Group; Rotational Atherectomy (RA) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patient with an indication for PCI including:
• Angina (stable or unstable),
• Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present),
• Non-ST Segment Elevation Myocardial Infarction (NSTEMI)
• Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
• Signed written informed consent
• Heavily calcified (severe)lesions necessitating atherectomy.
• The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤4.00 mm.
• Lesion length between 20 mm and 50mm

You may not qualify if:

• Estimated creatinine clearance \<30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis;
• ST-elevation Myocardial Infarction (STEMI) within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital.
• PCI within 24 hours preceding the study procedure.
• Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including intra-aortic balloon pump (IABP), at time of procedure.
• Mobitz II second degree or complete heart block
• Malignant ventricular arrhythmias requiring treatment
• Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (\>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema
• Subject is intubated.
• Known left ventricular ejection fraction (LVEF) \<35%.
• Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
• Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
• Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment).
• Patients with no prior MI/scarring in the subtended myocardial territory.
• Patients with no contraindication for MRI studies
• Patients who could safely receive Gadolinium (i.e. estimated glomerular filtration rate (eGFR) \>30)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Ziad A. Ali, MD Assistant Professor of Medicine
• Organization: Columbia University Irving Medical Center

zaa2112@cumc.columbia.edu

212-305-7060

Study Officials

• Ziad A. Ali, MD

  Columbia University

  STUDY CHAIR

• Jeffrey W. Moses, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology in Medicine

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: January 16, 2017
• Study Start: January 25, 2017
• Primary Completion: March 16, 2019
• Study Completion: March 16, 2019
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)