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Sapphire 3 CTO Study

NCT06358508 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-01-12

No results posted yet for this study

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

DEVICE

Sapphire 3 Coronary Dilatation Catheter

To 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.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Piedmont Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2025-10-21
Completion
2025-10-21
FDA Device
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06358508 on ClinicalTrials.gov