Trial Outcomes & Findings for Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in PCI (NCT NCT03021577)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

Up to 1 hour

Results posted on

2025-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Orbital Atherectomy System (OAS) Group OAS was used in percutaneous coronary intervention (PCI) of participants.	Rotational Atherectomy (RA) Group RA was used in percutaneous coronary intervention (PCI) of participants.
Overall Study STARTED	17	20
Overall Study COMPLETED	17	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Orbital Atherectomy System (OAS) Group n=17 Participants OAS was used in percutaneous coronary intervention (PCI) of participants.	Rotational Atherectomy (RA) Group n=20 Participants RA was used in percutaneous coronary intervention (PCI) of participants.	Total n=37 Participants Total of all reporting groups
Age, Customized ≥ 18 years	17 Participants n=17 Participants	20 Participants n=20 Participants	37 Participants n=37 Participants
Sex: Female, Male Female	6 Participants n=17 Participants	5 Participants n=20 Participants	11 Participants n=37 Participants
Sex: Female, Male Male	11 Participants n=17 Participants	15 Participants n=20 Participants	26 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Orbital Atherectomy System (OAS) Group n=17 Participants OAS was used in percutaneous coronary intervention (PCI) of participants.	Rotational Atherectomy (RA) Group n=20 Participants RA was used in percutaneous coronary intervention (PCI) of participants.
Index of Microcirculatory Resistance (IMR)	15 mmHg·s Interval 13.0 to 17.0	25 mmHg·s Interval 14.0 to 53.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Orbital Atherectomy System (OAS) Group n=17 Participants OAS was used in percutaneous coronary intervention (PCI) of participants.	Rotational Atherectomy (RA) Group n=20 Participants RA was used in percutaneous coronary intervention (PCI) of participants.
Fractional Flow Reserve (FFR)	0.85 ratio Interval 0.85 to 0.88	0.88 ratio Interval 0.87 to 0.93

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Orbital Atherectomy System (OAS) Group n=17 Participants OAS was used in percutaneous coronary intervention (PCI) of participants.	Rotational Atherectomy (RA) Group n=20 Participants RA was used in percutaneous coronary intervention (PCI) of participants.
Coronary Flow Reserve (CFR)	1.9 ratio Interval 1.3 to 3.1	2.3 ratio Interval 1.2 to 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 hour

Population: 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.

Blood test that helps determine incidence of peri-PCI myonecrosis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 hour

Population: 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.

Blood test that helps determine incidence of peri-PCI myonecrosis.

Outcome measures

Outcome data not reported

Adverse Events

Orbital Atherectomy System (OAS) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rotational Atherectomy (RA) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ziad A. Ali, MD Assistant Professor of Medicine

Columbia University Irving Medical Center

Phone: 212-305-7060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place