NCT03021577

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
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.
DEVICE	Rotablator Rotational Atherectomy System	The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console
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.

Timeline

• Start date: 2017-01-25
• Primary completion: 2019-03-16
• Completion: 2019-03-16
• First posted: 2017-01-16
• Last updated: 2025-08-06
• Results posted: 2025-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study