NCT07646444

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

May 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

May 28, 2026

Last Update Submit

June 10, 2026

Conditions

Coronary Arterial Disease (CAD)In Stent RestenosisCalcified Coronary Lesions

Outcome Measures

Primary Outcomes (3)

  • In-Hospital Outcomes

    Descriptive summaries of incidence of in-hospital outcomes and MACE

    periprocedural

  • Treatment Utilization

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

    intra-procedural

  • Predictors of Success and Failure for the OPN Balloon

    Assess predictors for failure of the OPN balloon

    intra-procedural

Interventions

non compliant balloonDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals over the age of 18 who have undergone clinically indicated PCI with the use of the OPN balloon

You may qualify if:

  • 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

You may not qualify if:

  • Subjects who have opted out of being included in research related data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Bavana V Rangan, BDS, MPH

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 12, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06