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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Troponin I Level | Blood test that helps determine incidence of peri-PCI myonecrosis. | 1 hour |
| Creatinine Kinase (CKMB) Level | Blood test that helps determine incidence of peri-PCI myonecrosis. |
Inclusion Criteria:
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.
Angiographic inclusion criteria:
Exclusion Criteria:
General Inclusion - MRI Sub-Study
Angiographic Exclusion Criteria:
General Inclusion - MRI Sub-Study
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| Name | Affiliation | Role |
|---|---|---|
| Ziad A. Ali, MD | Columbia University | Study Chair |
| Jeffrey W. Moses, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Orbital Atherectomy System (OAS) Group | OAS was used in percutaneous coronary intervention (PCI) of participants. |
| FG001 | Rotational Atherectomy (RA) Group | RA was used in percutaneous coronary intervention (PCI) of participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Orbital Atherectomy System (OAS) Group | OAS was used in percutaneous coronary intervention (PCI) of participants. |
| BG001 | Rotational Atherectomy (RA) Group | RA was used in percutaneous coronary intervention (PCI) of participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | mmHg·s | Up to 1 hour |
|
Up to 18 hours post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Orbital Atherectomy System (OAS) Group | OAS was used in percutaneous coronary intervention (PCI) of participants. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ziad A. Ali, MD Assistant Professor of Medicine | Columbia University Irving Medical Center | 212-305-7060 | zaa2112@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2020 | May 16, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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|
| Rotablator Rotational Atherectomy System | Device | The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console |
|
| 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. |
|
| 1 hour |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | ratio | Up to 1 hour |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | ratio | Up to 1 hour |
|
|
|
| Other Pre-specified | Troponin I Level | Blood test that helps determine incidence of peri-PCI myonecrosis. | Data was not collected due to PI's departure from the institution following completion of data collection for the purposes of the Primary Outcome Measures. | Posted | 1 hour |
|
|
| Other Pre-specified | Creatinine Kinase (CKMB) Level | Blood test that helps determine incidence of peri-PCI myonecrosis. | Data was not collected due to PI's departure from the institution following completion of data collection for the purposes of the Primary Outcome Measures. | Posted | 1 hour |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Rotational Atherectomy (RA) Group | RA was used in percutaneous coronary intervention (PCI) of participants. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |