Clinical Trial

OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

Name: OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions — clinical trial record (NCT07646444)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: OPEN-SAFE

Recruiting

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Summary

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

Protocol Amendment History 1 change

critical Recruitment opened 2026-08-11

Trial Details

NCT Number	NCT07646444
Lead Sponsor	Minneapolis Heart Institute Foundation
Conditions	Coronary Arterial Disease (CAD), In Stent Restenosis, Calcified Coronary Lesions
Enrollment	300 participants
Start Date	2026-08
Primary Completion	2027-01 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-10