Home › NCT07646444

OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

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

About the study

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

What is being tested

• non compliant balloon (device)

Sponsor: Minneapolis Heart Institute Foundation · Participants: 300 · Started: 2026-08

Contact the study team

• Bavana V Rangan, BDS, MPH · Phone: 612-863-4768

Official record on ClinicalTrials.gov — NCT07646444

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.