Coronary Stenosis Clinical Trial
Official title:
A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease
Verified date | February 2024 |
Source | Sino Medical Sciences Technology Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
Status | Completed |
Enrollment | 136 |
Est. completion date | November 23, 2022 |
Est. primary completion date | November 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. The patient is at least 18 to 75 years of age, male or not pregnant female. 2. Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction. 3. De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis. 4. Reference vessel diameter (RVD) must be visually estimated = 2.5 and = 5.0mm, and the vessel length must be no more than 30mm. 5. Target lesion(s) must have a diameter stenosis of (a) =70% by visual estimation or (b) >50% with evidence of ischemia. 6. The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels. 7. Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation. 8. Able to understand the purpose of the trial, voluntarily participate and sign the informed consent. Exclusion Criteria: 1. Evidence of ongoing acute myocardial infarction within a week. 2. Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion. 3. Severe calcification and Target lesion in a severe angulation (> 45 degrees). 4. Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) <40%. 5. Patient with renal dysfunction, as Cr>176.82umol/L or Cr >2.0 mg/dl. 6. Patient with active gastrointestinal bleeding history, any other evidence based bleeding, such as suspected liver failure disease, suffered from cerebral bleeding history, stroke during the last 6 months, with contra-indication of anti-platelet or anti-coagulation. 7. Patients with allergies to heparin and contrast media. 8. Target lesion demonstrating severe dissection prior to planned deployment of the trial device. 9. Visible thrombus at the target lesion. 10. Patients received heart transplantation. 11. Participation in another clinical trial (12 months after index procedure). 12. Those who participated in another clinical trials, but did not reach the primary endpoint. |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | |
China | Peking University Third Hospital | Beijing | |
China | Kaifeng Central Hospital | Kaifeng | |
China | The First People's Hospital of Lianyungang | Lianyungang | |
China | Tianjin Chest Hospital | Tianjin | |
China | Tianjin Forth Central Hospital | Tianjin | |
China | Wuxi People's Hospital | Wuxi | |
China | Xuzhou cancer hospital | Xuzhou |
Lead Sponsor | Collaborator |
---|---|
Sino Medical Sciences Technology Inc. | Peking University First Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Device procedural success (lesion level) | Defined as: Successful delivery, inflation, deflation, and withdrawal of the study balloon; and =30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%) | immediate post-intervention(approximately 1.4 hour) | |
Secondary | Rate of Procedural success (patient level) | Defined as: =30% final diameter stenosis following completion of the interventional procedure, including adjunctive stenting (For ISR or DCB related stenosis, Final diameter stenosis<50%); and freedom from major adverse cardiac events (MACE) during hospitalization | during the hospital stay, an average of 7 days post-procedure | |
Secondary | Rate of Target lesion failure (TLF) | a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CI-TLR) | during the hospital stay, an average of 7 days post-procedure | |
Secondary | Rate of Patient-oriented composite endpoint (POCE) | a composite of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization | during the hospital stay, an average of 7 days post-procedure | |
Secondary | Incidence of any AE and SAE incidence | report any AE results from a device deficiency or other device issue as related to the use of the study device. Such as Balloon burst?vascular perforation, dissection, acute occlusion, vasospasm, thrombosis (including stent thrombosis), arrhythmia requiring intervention, and so on. | during the hospital stay, an average of 7 days post-procedure | |
Secondary | Rate of device defect | report any device defect during hospitalization | during the hospital stay, an average of 7 days post-procedure |
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