Arteriosclerosis, Cardiovascular Diseases, Chronic Total Occlusion, Chronic Total Occlusion of Coronary Artery, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia
Conditions
Keywords
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases, Chronic Total Occlusion, Chronic Total Occlusion of Coronary Artery
Brief 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.
Interventions
DEVICESapphire 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
Avania
OrbusNeich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. 3. 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. 4. 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. Angiographic Inclusion Criteria 5. 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. 6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries. 7. 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. 8. The Target lesion is intended for stent placement during this index procedure. Clinical
Exclusion criteria
1. 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. 2. 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). 3. 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. 4. 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. 5. A serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure. 6. Cerebrovascular accident (CVA) within the past 6 months. 7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months. 8. 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). Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device Procedural Success | 24 hours post-procedure or hospital discharge, whichever comes first | Device procedural success consisting of the following: * Successful delivery, inflation, deflation and withdrawal of the study balloon and after the guidewire has successfully crossed the CTO lesion into the true lumen of the vessel * No evidence of vessel perforation or dissections (Grade C or higher) related to the study balloon * Final TIMI flow grade of II or III at the conclusion of the PCI procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Deaths (Cardiac and Non-Cardiac) | 24 hours post-procedure or hospital discharge, whichever comes first | All death (cardiac and non-cardiac) |
| Number of Participants With Myocardial Infarctions (MI) | 24 hours post-procedure or hospital discharge, whichever comes first | Myocardial Infarctions (MI) |
| Number of Participants With Target Lesion Revascularization (TLR) | 24 hours post-procedure or hospital discharge, whichever comes first | Target Lesion Revascularization (TLR) |
| Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel | 24 hours post-procedure or hospital discharge, whichever comes first | In-hospital stent thrombosis (ST) Within the Target Vessel |
| Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | 24 hours post-procedure or hospital discharge, whichever comes first | In-hospital Major Adverse Cardiac Events (MACE) which is a hierarchical composite of: * All death (cardiac and non-cardiac) * Myocardial infarction (MI) * Target Lesion Revascularization (TLR) |
| Number of Participants With Absence of Sapphire 3 Study Balloon Rupture | Peri-procedural | Absence of Sapphire 3 Study Balloon Rupture |
| Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA) | Peri-procedural | Improvement in Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (measured by QCA). Improvement in MLD is defined as MLD post use of Sapphire 3 as greater than MLD from baseline. |
| Number of Participants With Technical Success | Peri-procedural | Technical Success defined as Achievement of TIMI grade II or greater antegrade flow in all ≥2.5-mm distal branch(es) with \<30% residual stenosis of the target CTO lesion at the completion of the procedure, (independently measured by the Angiographic Core Lab using QCA). |
| Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) | 24 hours post-procedure or hospital discharge, whichever comes first | Clinically Significant Arrhythmias (Requiring Intervention) |
Countries
Spain, United States
Outcome results
None listed