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

Primary Purpose

Coronary Artery Disease (CAD)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Orbital Atherectomy System (OAS)

Rotablator Rotational Atherectomy System

Magnetic Resonance Imaging (MRI)

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease (CAD) focused on measuring orbital atherectomy system, rotational atherectomy, Fractional flow reserve, coronary flow reserve, index of microcirculatory resistance (IMR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Angiographic inclusion criteria:

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

Exclusion Criteria:

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).

General Inclusion - MRI Sub-Study

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)

Angiographic Exclusion Criteria:

Lesion length <20mm
Study target lesion in a bypass graft
Ostial right coronary artery (RCA) study target lesion
Chronic total occlusion (Thrombolysis In Myocardial Infarction (TIMI) flow 0/1) study target lesion
Bifurcation study lesion with a planned dual stent strategy
In-stent restenosis study target lesion

General Inclusion - MRI Sub-Study

Patients with no prior myocardial infarction (MI)/scarring in the subtended myocardial territory.
Patients with no contraindication for Magnetic resonance imaging (MRI) studies
Patients who could safely receive Gadolinium (i.e. eGFR>30)

Sites / Locations

Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Orbital Atherectomy System (OAS) Group

Rotational Atherectomy (RA) Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Creatinine Kinase (CKMB) level

Blood test that helps determine incidence of peri-PCI myonecrosis.

Troponin I level

Blood test that helps determine incidence of peri-PCI myonecrosis.

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.

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.

Full Information

NCT ID

NCT03021577

First Posted

December 5, 2016

Last Updated

March 22, 2019

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT03021577

Brief Title

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

Acronym

ORACLE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

January 25, 2017 (Actual)

Primary Completion Date

March 16, 2019 (Actual)

Study Completion Date

March 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The presence of heavily calcified coronary lesions necessitates the use of ablative devices that aid in successful percutaneous coronary intervention (PCI). However, atherectomy devices generate microparticles that embolize to the distal coronary microcirculation and may compromise myocardial tissue perfusion. Two mechanisms that deserve particular attention are the eccentric mounting of the OAS crown and the higher flow rates on the vasodilator flush. Firstly, as opposed to rotational atherectomy where the larger, centrally mounted burr may cause obstruction of flow during the atherectomy, the smaller eccentrically mounted crown in OAS allows continuous perfusion during both atherectomy as well as rest periods. Second, both during rest and atherectomy, the flow rates of vasodilatory flush is higher in OAS compared to RA. Combined, these differences in coronary and vasodilator flush flow could lead to improved perfusion of the distal circulation, particularly during the atherectomy runs when risk of embolization is highest. The loss of microcirculatory function can be transient, with partial or complete restoration of microcirculatory blood flow, or permanent. As shown in studies of patients with acute coronary syndromes, the loss of microcirculatory function is a critical and independent predictor of myocardial recovery and adverse outcomes. The putative protective effects of OAS on coronary microvasculature may therefore be of major clinical significance and impact.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease (CAD)

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Orbital Atherectomy System (OAS) Group

Arm Type

Active Comparator

Arm Description

Arm Title

Rotational Atherectomy (RA) Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Orbital Atherectomy System (OAS)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Rotablator Rotational Atherectomy System

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging (MRI)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Index of microcirculatory resistance (IMR)

Description

Time Frame

Up to 1 hour

Secondary Outcome Measure Information:

Title

Creatinine Kinase (CKMB) level

Description

Blood test that helps determine incidence of peri-PCI myonecrosis.

Time Frame

1 hour

Title

Troponin I level

Description

Blood test that helps determine incidence of peri-PCI myonecrosis.

Time Frame

1 hour

Title

Fractional flow reserve (FFR)

Description

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.

Time Frame

Up to 1 hour

Title

Coronary flow reserve (CFR)

Description

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

Time Frame

Up to 1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Angiographic inclusion criteria: 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 Exclusion Criteria: 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). General Inclusion - MRI Sub-Study 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) Angiographic Exclusion Criteria: Lesion length <20mm Study target lesion in a bypass graft Ostial right coronary artery (RCA) study target lesion Chronic total occlusion (Thrombolysis In Myocardial Infarction (TIMI) flow 0/1) study target lesion Bifurcation study lesion with a planned dual stent strategy In-stent restenosis study target lesion General Inclusion - MRI Sub-Study Patients with no prior myocardial infarction (MI)/scarring in the subtended myocardial territory. Patients with no contraindication for Magnetic resonance imaging (MRI) studies Patients who could safely receive Gadolinium (i.e. eGFR>30)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ziad A. Ali, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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