Clinical Trials Directory

Trials / Completed

CompletedNCT06358508

Sapphire 3 CTO Study

Sapphire 3 - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Performance of the Sapphire 3 0.85-1.25 mm Coronary Dilatation Catheter in Predilatation of Chronic Total Occlusion (CTO) Lesions During Percutaneous Coronary Intervention.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
170 (actual)
Sponsor
OrbusNeich · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention. One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first.

Conditions

Interventions

TypeNameDescription
DEVICESapphire 3 Coronary Dilatation CatheterTo pre-dilate Chronic Total Occlusion (CTO) lesions in coronary arteries during the subject's index procedure with Sapphire 3 0.85mm, 1.0mm, and 1.25mm diameter Coronary Dilatation Catheters.

Timeline

Start date
2024-11-06
Primary completion
2025-10-21
Completion
2025-10-21
First posted
2024-04-10
Last updated
2026-01-12

Locations

14 sites across 2 countries: United States, Spain

Regulatory

Source: ClinicalTrials.gov record NCT06358508. Inclusion in this directory is not an endorsement.