New balloon device shows promise in clearing hardened heart blockages

NCT ID NCT06358508

Completed Disease control Sponsor: OrbusNeich Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a very small balloon catheter (Sapphire 3) in 170 people with severely blocked heart arteries (chronic total occlusions). The balloon was used to open the blockage before placing a stent. The main goal was to see if the device could be safely delivered, inflated, and removed without causing serious damage. Results focused on immediate success and safety during the hospital stay.

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Conditions

The condition(s) this trial relates to.

arteriosclerosis disorder cardiovascular disorder coronary artery disorder Coronary Disease heart disorder myocardial ischemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ARTERIOSCLEROSIS CARDIOVASCULAR DISEASES CHRONIC TOTAL OCCLUSION CHRONIC TOTAL OCCLUSION OF CORONARY ARTERY CORONARY ARTERY DISEASE CORONARY DISEASE HEART DISEASES MYOCARDIAL ISCHEMIA

Contacts and locations

Locations

Atlanta VA Health Care System

Decatur, Georgia, 30033, United States
Brigham and Women's Hospital Heart and Vascular Center

Boston, Massachusetts, 02115, United States
Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Henry Ford Health System

Detroit, Michigan, 48202, United States
Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain
Hospital Universitari de Bellvitge

Barcelona, 08907, Spain
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States
Stanford Health Care

Stanford, California, 94305, United States
Torrance Memorial Medical Center

Torrance, California, 90505, United States
University of Washington

Seattle, Washington, 98195, United States

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