CompletedNot Applicable

Sapphire 3 CTO Study

United States170 participantsStarted 2024-11-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is ≥ 18 years of age.
✓. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
✓. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.
✓. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization with planned stent placement during this index procedure.
✓. Subject must have at least one de novo or restenotic lesion in native coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 and is estimated to be at least 3 months in duration by clinical, angiographic, or electrocardiographic criteria.
✓. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
✓. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success by visual assessment.
✓. The Target lesion is intended for stent placement during this index procedure.

What they're measuring

Number of Participants With Device Procedural Success

Timeframe: 24 hours post-procedure or hospital discharge, whichever comes first

Trial details

NCT IDNCT06358508

SponsorOrbusNeich

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-21

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is ≥ 18 years of age.
✓. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
✓. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.
✓. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization with planned stent placement during this index procedure.
✓. Subject must have at least one de novo or restenotic lesion in native coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 and is estimated to be at least 3 months in duration by clinical, angiographic, or electrocardiographic criteria.
✓. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
✓. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success by visual assessment.
✓. The Target lesion is intended for stent placement during this index procedure.

Sapphire 3 CTO Study

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Sapphire 3 CTO Study

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria