Coronary Arteriosclerosis
Conditions
Keywords
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
Brief summary
To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.
Detailed description
This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 210 subjects. All subjects enrolled will be randomly assigned to the test group (n=105) and the control group (n=105). Subjects in the test group and the control group will receive Scoreflex TRIO Scoring PTCA catheters and Scoreflex NC Scoring PTCA catheters respectively.
Interventions
DEVICEOrbusNeich Scoreflex TRIO
To dilate coronary arteries during the subject's index procedure with Scoreflex TRIO Scoring PTCA catheters
DEVICEOrbusNeich Scoreflex NC
To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Sponsors
CCRC Medtech (Shanghai) Co., Ltd.
OrbusNeich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and≤ 80. 2. Volunteer to participate in this trial and provide the written informed consent. 3. Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, stable / unstable angina or silent ischemia, need percutaneous coronary intervention. Angiographic Inclusion Criteria 4. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention. 5. A maximum of two lesions that needed to be treated and they are located in two coronary arteries, including at least one target lesion, in up to two coronary arteries. 6. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation. 7. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation. 8. The non-target lesion must be located in different coronary artery from the Target lesion. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician.
Exclusion criteria
1. STEMI or NSTEMI within 7 days of study screening. 2. A serum creatinine level \> 2.0 mg/dl within 7 days prior to index procedure. 3. Cerebrovascular accident (CVA) within the past 6 months. 4. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months. 5. Left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary) 6. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, 7. Subject is known to be allergic to the ingredients of the test product and the sensitivity to contrast media. 8. 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. 9. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure. 10. Subjects who are participating in clinical research of other drugs and devices. 11. Other conditions assessed by the investigator as inappropriate to participate in this trial. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device Procedural Success | Peri-procedural (at Day 0) | Device procedural success consisting of the following: * Successful delivery, inflation, deflation, and withdrawal of the device * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the devices * Residual stenosis of target lesion \<50% after balloon angioplasty, Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA). | Peri-procedural (at Day 0) | Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline. |
| In-hospital Major Adverse Cardiac Events (MACE) | Endpoints will be measured through hospital discharge (expected to be within 24 hours) | In-hospital Major Adverse Cardiac Events (MACE), a composite of: Cardiac death, Myocardial Infarction (MI), Target Lesion Revascularization (TLR), clinically driven. |
| Device-oriented target lesion failure (TLF) | 30 days | The device-oriented target lesion failure (TLF) is defined as a composite of cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (i-TLR) |
| Patient-oriented composite endpoint | 30 days | The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization. |
Countries
China
Outcome results
None listed