Recruiting

SIS-OPN

Sponsor:

Minneapolis Heart Institute Foundation

Code:

NCT07646444

Conditions

Coronary Arterial Disease (CAD)

In Stent Restenosis

Calcified Coronary Lesions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

non compliant balloon

Study Details

Brief summary:

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

Conditions

Coronary Arterial Disease (CAD)

In Stent Restenosis

Calcified Coronary Lesions

Study ID

NCT07646444

Start date

Aug, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

non compliant balloon

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

Primary outcome measure

  • In-Hospital Outcomes [ Time Frame: periprocedural ]
  • Treatment Utilization [ Time Frame: intra-procedural ]
  • Predictors of Success and Failure for the OPN Balloon [ Time Frame: intra-procedural ]

Central Contacts and Locations

Central contacts

Bavana V Rangan, BDS, MPH

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

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Bavana Rangan, BDS, MPH

612-863-4768bavana.rangan@allina.com

More Information

Sponsor

Minneapolis Heart Institute Foundation

Last update posted

Aug 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation on 2026-08-10.