OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

Recruiting now

Conditions studied: Coronary Arterial Disease (CAD), In Stent Restenosis, Calcified Coronary Lesions

In brief

The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.

Key facts

Study ID

NCT07646444

Run by

Minneapolis Heart Institute Foundation

People needed

300

Starts

2026-08-01

Expected to finish

2027-06-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Subjects who underwent a clinically indicated PCI procedure that involved at least one OPN balloon
• Date range for data collection will be from February 1, 2023 to December 31, 2028

You may not qualify if…

• Subjects who have opted out of being included in research related data collection

Where it is running

• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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