U.S., June 13 -- ClinicalTrials.gov registry received information related to the study (NCT07646444) titled 'OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions' on May 28.
Brief Summary: The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
Study Start Date: June, 2026
Study Type: OBSERVATIONAL
Condition:
Coronary Arterial Disease (CAD)
In Stent Restenosis
Calcified Coronary Lesions
Intervention:
DEVICE: non compliant balloon
This is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon
Recruitment Status: NOT_YET_RECRUITING
Sponsor: Minneapolis Heart Institute Foundation
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