OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

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

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Key information

Conditions

Coronary Arterial Disease (CAD) Calcified Coronary Lesions In Stent Restenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non compliant balloon

Device

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

Primary outcomes

In-Hospital Outcomes

Time frame: periprocedural

Descriptive summaries of incidence of in-hospital outcomes and MACE
Treatment Utilization

Time frame: intra-procedural

descriptive summaries of various treatments utilized before and after use of the OPN balloon
Predictors of Success and Failure for the OPN Balloon

Time frame: intra-procedural

Assess predictors for failure of the OPN balloon

Study contacts

Contact information is provided by the study sponsor or research team.

Bavana V Rangan, BDS, MPH

CONTACT

[email protected]

612-863-4768

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Registry information

Official study title

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

Acronym: OPEN-SAFE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 12, 2026
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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