Coronary Flow Reserve Following Orbital Atherectomy

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Coronary Orbital Atherectomy plus Stenting

• Registration Number: NCT02339545
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.

Detailed Description

This is an acute, observational, prospective, multi-center clinical study, evaluating coronary flow reserve (CFR) using the Volcano FloWire®. Subjects will be evaluated after treatment with orbital atherectomy and stenting of de-novo severely calcified lesions, due to coronary artery disease.

Subjects who undergo successful revascularization using the Diamondback 360® Coronary Orbital Atherectomy System (OAS) and stenting are eligible for enrollment. Coronary blood flow of enrolled subjects will be measured with the Volcano FloWire®, Doppler velocity data recorded intra-procedurally, and major adverse cardiac events (MACE) assessed at 24 hours or at discharge, whichever is earlier.

Determination of CFR by Doppler flow measurements can assess physiological changes in the distal vascular bed. The primary endpoint of this study will evaluate coronary flow reserve after successful treatment of severely calcified coronary lesions using OAS and stent deployment. The secondary endpoint will measure the occurrence of post-procedural Major Adverse Cardiac Events (MACE), including cardiac death, acute myocardial infarction (Q wave or non-Q wave), and target vessel revascularization.

Study Timeline

• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-15
• Study Start: 2015-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2019-04-08
• Results First Submitted QC: 2019-04-08
• Results First Posted: 2019-07-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Enrolled Subjects	Coronary Orbital Atherectomy plus Stenting	All subjects will receive Coronary Flow Reserve (CFR) measurements post successful orbital atherectomy treatment and stenting.

Primary Outcome Measures

Name	Time	Method
Coronary Flow Reserve (CFR)	Intra-procedurally following successful stent placement. Average procedure time 56 minutes.	CFR was measured after successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions. It was calculated from coronary blood flow velocity measurements, which were derived from Doppler-velocity wire data recorded in real time. The CFR formula utilized was APVp/APVb, where APVb is the average peak velocity at baseline and APVp is peak hyperemia.

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	At 24 hours or at time of hospital discharge, whichever occurred first	MACE: cardiac death, acute myocardial infarction (Q wave or non-Q wave), or target vessel revascularization.

Trial Locations

Locations (3)

St. Francis Hospital; 🇺🇸 Roslyn, New York, United States

Chandler Regional Medical Center and Mercy Gilbert Medical Center; 🇺🇸 Chandler, Arizona, United States

Mercy Hospital; 🇺🇸 Coon Rapids, Minnesota, United States