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OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

RECRUITINGSponsored by Minneapolis Heart Institute Foundation
Actively Recruiting
SponsorMinneapolis Heart Institute Foundation
Started2026-08
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07646444

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Calcified Coronary LesionsCoronary Arterial Disease (CAD)Heart DiseaseIn-stent Restenosis

Locations1 site

Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Bavana Rangan, BDS, MPH612-863-4768bavana.rangan@allina.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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