RecruitingNCT07646444

OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

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


Sponsor

Minneapolis Heart Institute Foundation

Enrollment

300 participants

Start Date

Aug 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called non compliant balloon for people with calcified coronary lesions, coronary arterial disease (cad), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEnon compliant balloon

This is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon


Locations(1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

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NCT07646444


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