Sapphire 3 CTO Study (NCT06358508) | Clinical Trial Compass
CompletedNot Applicable
Sapphire 3 CTO Study
United States, Spain170 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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Device Procedural Success
Timeframe: 24 hours post-procedure or hospital discharge, whichever comes first
. 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.
Exclusion criteria
. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
. Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as CK-MB or troponin greater than 1X the upper limit of normal (ULN).
. Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
. Planned or actual target lesion treatment prior to the use of the Study Device with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
. A serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure.
. Cerebrovascular accident (CVA) within the past 6 months.
. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
. Subject has a known left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary).