Coronary Artery Disease Clinical Trial
Official title:
A Prospective, Open Label, Multi-center, Randomized Study Designed to Evaluate the Safety and Efficacy of Scoring PTCA Catheter on Subjects During Percutaneous Coronary Intervention
NCT number | NCT06214247 |
Other study ID # | 814 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 27, 2021 |
Est. completion date | May 17, 2022 |
Verified date | January 2024 |
Source | BrosMed Medical Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 198 |
Est. completion date | May 17, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 ?-?) 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. |
Country | Name | City | State |
---|---|---|---|
China | Dongguan People's Hospital | Dongguan | Guangdong |
China | Dongguan Tongwah Hospital | Dongguan | Guangdong |
China | Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
China | Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | The Affiliated Hospital of Hangzhou Normal University | Hangzhou | Zhejiang |
China | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | Huzhou Central Hospital | Huzhou | Zhejiang |
China | Ningbo First Hospital | Ningbo | Zhejiang |
China | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
China | The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
China | Wenzhou People's Hospital | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
BrosMed Medical Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure Success Rate | 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. | before discharge or within 3 days after the procedure | |
Secondary | Clinical Success Rate | 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) | 30-day follow-up after procedure | |
Secondary | Device Procedural Success Rate | The following conditions need to be met for the successful balloon dilatation of stenotic lesions: Successful delivery, inflation, deflation, and withdrawal of the study balloon. 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 |
Immediately after procedure | |
Secondary | Minimum Luminal Diameter (MLD) | The minimal diameter of the target lesion, evaluated by quantitative coronary analysis (QCA). | Immediately after procedure | |
Secondary | Percent of Diameter Stenosis(%DS) | %DS = (RVD - MLD) / RVD × 100%, MLD refers to the immediately postoperative minimum luminal diameter, RVD refers to the reference vessel diameter. | Immediately after procedure | |
Secondary | Acute Lumen Gain (ALG) | ALG = immediately postoperative MLD - preoperative MLD | Immediately after procedure | |
Secondary | Balloon Slippage Rate | Balloon slippage is defined as a forward or backward movement of the balloon of at least 3mm during its inflation at the lesion site | Immediately after procedure | |
Secondary | Surgical complication | Incidence of Complications in a Single Operation | Day 0 | |
Secondary | Rate of Adverse Events | 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 | Month 3 |
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