NCT02339545

Coronary Flow Reserve Following Orbital Atherectomy

Coronary Flow Reserve Following Orbital Atherectomy and Percutaneous Revascularization in Severely Calcified Coronary Lesions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Coronary Orbital Atherectomy plus Stenting

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-01-15
• Last updated: 2023-07-18
• Results posted: 2019-07-05

Locations

3 sites across 1 country: United States