OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

N/ARecruitingNCT07646444

Minneapolis Heart Institute Foundation300 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

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

Interventions

non compliant balloonDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

In-Hospital Outcomes

Descriptive summaries of incidence of in-hospital outcomes and MACE

Time frame: periprocedural

Treatment Utilization

descriptive summaries of various treatments utilized before and after use of the OPN balloon

Time frame: intra-procedural

Predictors of Success and Failure for the OPN Balloon

Assess predictors for failure of the OPN balloon

Time frame: intra-procedural

Central Contacts

Bavana V Rangan, BDS, MPH

CONTACT

612-863-4768 Bavana.Rangan@allina.com

Data from ClinicalTrials.gov

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