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

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease (CAD)
• Intervention / Treatment: Device: Orbital Atherectomy System (OAS); Procedure: Magnetic Resonance Imaging (MRI); Device: Rotablator Rotational Atherectomy System

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years

2. 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)
3. Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
4. Signed written informed consent
5. Heavily calcified (severe)lesions necessitating atherectomy.

Angiographic inclusion criteria:

1. 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.
2. Lesion length between 20 mm and 50mm

Exclusion Criteria:

1. Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis;
2. 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.
3. PCI within 24 hours preceding the study procedure.
4. 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.
5. Mobitz II second degree or complete heart block
6. Malignant ventricular arrhythmias requiring treatment
7. 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
8. Subject is intubated.
9. Known left ventricular ejection fraction (LVEF) <35%.
10. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
11. Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
12. 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

1. Patients with no prior MI/scarring in the subtended myocardial territory.
2. Patients with no contraindication for MRI studies
3. Patients who could safely receive Gadolinium (i.e. estimated glomerular filtration rate (eGFR) >30)

Angiographic Exclusion Criteria:

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

General Inclusion - MRI Sub-Study

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Orbital Atherectomy System (OAS) Group; 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); 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.; 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.
Active Comparator: Rotational Atherectomy (RA) Group; 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.	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.; Device: Rotablator Rotational Atherectomy System; The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatinine Kinase (CKMB) level	Blood test that helps determine incidence of peri-PCI myonecrosis.	1 hour
Troponin I level	Blood test that helps determine incidence of peri-PCI myonecrosis.	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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Ziad A. Ali, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): March 16, 2019
• Study Completion (Actual): March 16, 2019

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: coronary flow reserve; Fractional flow reserve; rotational atherectomy; orbital atherectomy system; index of microcirculatory resistance (IMR)
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: AAAQ9267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No