Coronary Artery Disease (CAD)ORACLENCT03021577
Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in PCI
A study testing Orbital Atherectomy System (OAS), Rotablator Rotational Atherectomy System and Magnetic Resonance Imaging (MRI) in people with Coronary Artery Disease (CAD), run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- Orbital Atherectomy System (OAS), Rotablator Rotational Atherectomy System and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2017to 16 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- Orbital Atherectomy System (OAS), Rotablator Rotational Atherectomy System, Magnetic Resonance Imaging (MRI)
- Keywords
- orbital atherectomy system, rotational atherectomy, Fractional flow reserve, coronary flow reserve, index of microcirculatory resistance (IMR)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Rotablator Rotational Atherectomy System; Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start25 Jan 2017
- Primary completion16 Mar 2019
- Study completion16 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey W. Moses, Columbia University
- Investigators
- Ziad A. Ali, MD, Study chair, Columbia UniversityJeffrey W. Moses, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021577
- Sponsor's protocol ID
- AAAQ9267
- Acronym
- ORACLE
- Status last verified
- Jul 2025
- First submitted
- 5 Dec 2016
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT03021577
- Acronym / sponsor ID
- ORACLE / AAAQ9267
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- orbital atherectomy system, rotational atherectomy, Fractional flow reserve, coronary flow reserve, index of microcirculatory resistance (IMR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 16 Mar 2019 (actual)
- Study completion
- 16 Mar 2019 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 6 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orbital Atherectomy System (OAS) Group | Active comparator | Device: Orbital Atherectomy System (OAS), Procedure: Magnetic Resonance Imaging (MRI)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. |
| Rotational Atherectomy (RA) Group | Active comparator | Device: Rotablator Rotational Atherectomy System, Procedure: Magnetic Resonance Imaging (MRI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Patient with an indication for PCI including:
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Orbital Atherectomy System (OAS) Group |
| Rotablator Rotational Atherectomy SystemThe Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console | Device | Rotational Atherectomy (RA) Group |
| 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. | Procedure or surgery | Orbital Atherectomy System (OAS) Group, Rotational Atherectomy (RA) Group |
Primary outcome
Index of Microcirculatory Resistance (IMR)
Time frame: Up to 1 hour
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.
Fractional Flow Reserve (FFR)
Time frame: Up to 1 hour
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)
Time frame: Up to 1 hour
Coronary Flow Reserve (CFR) is the ratio between hyperemic and basal coronary flow. CFR=Hyperemic Flow /Resting Flow. This is for micro vascular function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziad A. Ali, MD study chair
Columbia University
Jeffrey W. Moses, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orbital Atherectomy System (OAS), Rotablator Rotational Atherectomy System and Magnetic Resonance Imaging (MRI) in people with Coronary Artery Disease (CAD), run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of Microcirculatory Resistance (IMR) (time frame: Up to 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.