Coronary Artery Disease
Conditions
Brief summary
To evaluate the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter for dilating coronary stenosis during PCI in comparison with a similar product on the market.
Detailed description
The prospective, multicenter, open-label, randomized clinical study is designed to verify the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter in the application of dilatating coronary artery stenosis during PCI in comparison with a similar product on the market. The study is planned to enroll 198 subjects, who are randomly assigned to the test group (99 cases) and the control group (99 cases).
Interventions
DEVICEWedge NC Scoring Balloon Dilatation Catheter
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Wedge NC Scoring Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure.
DEVICEScoreflex Scoring Balloon Dilatation Catheter
During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using a similar product on the market in the control group, subsequently completing the remaining procedure.
Sponsors
BrosMed Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years old. 2. 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. 3. Subjects with coronary artery stenosis confirmed by imaging examination are suitable for percutaneous coronary intervention (PCI). 4. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. 5. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention. 6. Target lesion with reference vessel diameter (RVD) of 2.0mm - 4.0mm, length ≤30mm (by visual inspection). 7. Only one lesion will be selected as the target lesion for revascularization when subjects have multiple lesions requiring treatment. Tandem lesions (defined as multiple lesions) are deemed one lesion if they can be covered by a single stent. 8. If target lesions and non-target lesions are treated simultaneously, they must be located in different coronary artery from the Target lesion
Exclusion criteria
1. Subjects with bleeding tendency, contraindications to antiplatelet agent and anticoagulant therapy, and inability to anticoagulant therapy. 2. Subjects are sensitivity to contrast media which cannot be adequately pre-medicated. 3. Subjects with severe renal failure, whether on dialysis or not, with a glomerular filtration rate (eGFR) level \< 30ml/min/1.73m2 or serum creatinine level\> 2.0 mg/dl within 7 days prior to index procedure. 4. Subjects with decompensated congestive heart failure or cardiogenic shock. 5. Subjects with expected life less than 12 months. 6. Subjects with an active peptic ulcer or active gastrointestinal bleeding within 1 month prior to index procedure. 7. Subjects with an embolic stroke or transient ischemic attack within 2 months prior to index procedure. 8. Subject with known pregnancy or is nursing. Women of child-bearing potential shall undertake a pregnancy test before index procedure. 9. Subjects enrolled in any other clinical trial within 1 month prior to the trial or currently. 10. Subjects who have poor compliance and cannot complete the trial as required. 11. Lesions with total coronary artery occlusion (TIMI 0 or 1). 12. Severe calcifications (grade Ⅲ-Ⅳ) or extreme angulation (\>90°), etc., and lesions are inability to pass the study balloon or stent. 13. Lesions with visible thrombosis or ulcers. 14. Lesions with significant intima tears. 15. Unprotected left main disease. 16. Lesions located within an artery/saphenous vein graft or graft anastomosis. 17. Coronary artery spasm without significant stenosis. 18. Saphenous vein graft degenerative disease 19. Other situations that the investigator considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success Rate | before discharge or within 3 days after the procedure | Procedure success is defined as the target lesion residual stenosis ≤30% right after PCI, without death, Q-wave or non-Q-wave myocardial infarction, or emergency coronary artery bypass grafting (CABG) during postoperative hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Procedural Success Rate | Immediately after procedure | The following conditions need to be met for the successful balloon dilatation of stenotic lesions: 1. Successful delivery, inflation, deflation, and withdrawal of the study balloon. 2. 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 study balloon |
| Minimum Luminal Diameter (MLD) | Immediately after procedure | The minimal diameter of the target lesion, evaluated by quantitative coronary analysis (QCA). |
| Percent of Diameter Stenosis(%DS) | Immediately after procedure | %DS = (RVD - MLD) / RVD × 100%, MLD refers to the immediately postoperative minimum luminal diameter, RVD refers to the reference vessel diameter. |
| Clinical Success Rate | 30-day follow-up after procedure | Clinical success is defined as the composite endpoint of no Major Adverse Cardiovascular Events (MACE) at follow-up, including cardiac death (also considered cardiac death if the cause of death is uncertain), target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) |
| Balloon Slippage Rate | Immediately after procedure | Balloon slippage is defined as a forward or backward movement of the balloon of at least 3mm during its inflation at the lesion site |
| Surgical complication | Day 0 | Incidence of Complications in a Single Operation |
| Rate of Adverse Events | Month 3 | Adverse events include death (cardiogenic death or non-cardiogenic death), acute myocardial infarction (Q wave or non-Q wave), target lesion revascularization (TLR), target vessel revascularization (TVR), other cardiac surgery and other cardiac adverse events, etc |
| Acute Lumen Gain (ALG) | Immediately after procedure | ALG = immediately postoperative MLD - preoperative MLD |
Countries
China
Outcome results
None listed