Trial Outcomes & Findings for Coronary Orbital Atherectomy System Study (NCT NCT02132611)

Last Updated: 2023-07-18

Results Overview

A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days. 30-Day MACE is composed of: * Cardiac death * Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave * Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

30 Days

Results posted on

2023-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Diamondback 360® Coronary OAS Micro Crown Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
Overall Study STARTED	100
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Diamondback 360® Coronary OAS Micro Crown Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
Overall Study Death	2

Baseline Characteristics

Coronary Orbital Atherectomy System Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diamondback 360® Coronary OAS Micro Crown n=100 Participants Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
Age, Continuous	70.7 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 participants n=5 Participants
Race/Ethnicity, Customized Japanese	26 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants
Race/Ethnicity, Customized White	65 participants n=5 Participants
Race/Ethnicity, Customized Unspecified	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Outcome measures

Outcome measures
Measure	Diamondback 360® Coronary OAS Micro Crown n=100 Participants Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
Major Adverse Cardiac Event (MACE)	85.0 Percent Probability of Freedom from MACE Interval 78.0 to 92.0

SECONDARY outcome

Timeframe: Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours

Procedural success was defined as success in facilitating stent delivery with a residual stenosis of \<50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.

Outcome measures

Outcome measures
Measure	Diamondback 360® Coronary OAS Micro Crown n=100 Participants Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
Procedural Success	85.0 percentage of procedures Interval 76.5 to 91.4

Adverse Events

Diamondback 360® Coronary OAS Micro Crown

Serious events: 27 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Diamondback 360® Coronary OAS Micro Crown n=100 participants at risk Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
Cardiac disorders Acute MI, Q-wave	2.0% 2/100 • Number of events 2 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Cardiac disorders Acute MI, non Q-wave	12.0% 12/100 • Number of events 12 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Cardiac disorders Acute Congestive Heart Failure	2.0% 2/100 • Number of events 2 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Cardiac disorders Atrial Fibrillation	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Cardiac disorders Coronary Artery Restenosis	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Cardiac disorders Ventricular Tachycardia	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Vascular disorders Carotid Artery Disease	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Vascular disorders Hematoma At Access Site, Not Requiring Intervention	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Vascular disorders Other Vascular Disorder	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Gastrointestinal disorders Gastrointestinal Bleeding	2.0% 2/100 • Number of events 2 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Renal and urinary disorders Renal Insufficiency	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Cardiac disorders Cardiac Death	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
General disorders Non-Cardiac Death	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
General disorders Abdominal Pain	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Blood and lymphatic system disorders Anemia	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
General disorders Chest Pain, Non-Cardiac	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Blood and lymphatic system disorders Thrombocytopenia	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
General disorders Trauma	1.0% 1/100 • Number of events 1 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Surgical and medical procedures Coronary Vessel Dissection Present	7.0% 7/100 • Number of events 7 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Surgical and medical procedures Coronary Vessel Perforation Present	2.0% 2/100 • Number of events 2 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
Surgical and medical procedures Slow Flow or No Reflow Phenomena	4.0% 4/100 • Number of events 4 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.

Other adverse events

Other adverse events
Measure	Diamondback 360® Coronary OAS Micro Crown n=100 participants at risk Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
Surgical and medical procedures Angiographic Complications	9.0% 9/100 • Number of events 9 • 30 Days Post Procedure Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.

Additional Information

Clinical Project Manager

Cardiovascular Systems, Inc.

Phone: 651-259-1600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any previously unpublished information provided to the Investigators by the Sponsor is confidential and will remain the sole property of the Sponsor. The Investigator agrees to use this information only in accomplishing this study not use it for other purposes without the Sponsor's written consent. An Investigator can generate additional publication ideas based on the trial data. The Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data.
Publication restrictions are in place

Restriction type: OTHER