NCT07646444Recruiting

OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

Minneapolis Heart Institute Foundation

Start Date

8/1/2026

Completion Date

6/1/2027

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

non compliant balloon

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Coronary Arterial Disease (CAD)In Stent RestenosisCalcified Coronary Lesions

Locations

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota 55407

United States

Run studies, or work at a research site?

Corterve helps sites and sponsors reach patients who are looking for trials. It does not determine eligibility and does not promise an enrolment outcome.

For sponsors, CROs and sites

What Corterve sells to organisations, and the anti-kickback constraints it works within.

Services and published prices

Coordinate outreach and marketing across multiple sites as one effort, plus study-site logistics and tech support.

For research sites

One published licence rate, the same for every site, and the fees a site is never charged.