OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Minneapolis Heart Institute Foundation
Study ID
NCT07646444
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jun 12, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

In-Hospital Outcomes [ Time Frame: periprocedural ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Bavana Rangan, BDS, MPH
[email protected]
612-863-4768

Find similar trials in Minneapolis, MN

By research site
Minneapolis Heart Institute Foundation· Minneapolis, MN

Related Studies