Coronary artery disease
Conditions
Interventions
Experimental group:Paclitaxel-Eluting PTCA Balloon Catheter
Control group:Paclitaxel drug-eluting coronary balloon catheter
Single group of extremely small vessels:Paclitaxel-Eluting PTCA Balloon Catheter
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria: (1) Age between 18 and 80 years old, regardless of gender; (2) Suitable for percutaneous coronary intervention and planned to undergo balloon angioplasty; (3) Able to understand the purpose of the trial, willing to cooperate with follow-up, and voluntarily sign the informed consent form. Angiographic inclusion criteria: (4) Primary coronary small vessel disease (visualized lesion vessel diameter >= 2.00mm and = 1.50mm and 70% and = 50% and = 50% and 70% and = 90%, regardless of whether the myocardial ischemia symptoms are typical; (6) Post-pre-dilation of the target lesion, visualized residual stenosis <= 30%, no C-type or higher dissection, and TIMI blood flow grade III; (7) Each subject can only be included in one target lesion (two lesions within the same vessel with a distance <= 10mm and a total length <= 36mm, which can be treated simultaneously with one balloon, can be regarded as one lesion); (8) A maximum of two non-target lesions can be treated simultaneously, and the non-target lesions cannot be in the same main branch as the target lesion. Non-target lesions should be treated first and have good treatment results (TIMI blood flow grade 3) and no severe complications (acute thrombosis, acute occlusion, coronary perforation, etc.).
Exclusion criteria
Exclusion criteria: General exclusion criteria: (1) Those who have experienced acute myocardial infarction within 7 days before enrollment; (2) Those with NYHA class IV heart function or with left ventricular ejection fraction (LVEF) < 30% as shown by echocardiography; (3) Those with renal insufficiency (eGFR < 30 ml/min) or failure of major organs; (4) Those who have had a stroke, gastrointestinal bleeding, or have a history of active gastric ulcer within 6 months before enrollment, or are judged by the investigator to have a bleeding diathesis; (5) Those with cardiogenic shock; (6) Those known to be allergic or intolerant to contrast agents or paclitaxel and/or its analogues; (7) Those intolerant or contraindicated to anticoagulant/antiplatelet drugs; (8) Those with severe valvular heart disease or a history of heart transplantation; (9) Those with an expected survival of no more than 1 year; (10) Pregnant or lactating women, or those with plans to become pregnant during the study period; (11) Those currently participating in other pre-market interventional drug or medical device clinical trials that have not reached the primary endpoint; (12) Those deemed by the investigator to be unsuitable for inclusion for other reasons; Angiographic exclusion criteria: (13) Completely occluded lesions (TIMI grade 0); (14) Coronary artery spasm without significant stenosis; (15) Lesions requiring simultaneous treatment of the left main coronary artery or three-vessel disease; (16) Lesions where both the main branch and the side branch of the target lesion require intervention; (17) Target lesions with severe tortuosity or severe calcification that hinders smooth passage of the catheter; (18) Secondary stenosis lesions caused by pre-dilation; (19) Clear thrombus in the target vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss (LLL) of the target lesion at 9 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Lesion success rate;Clinical success rate;The degree of diameter stenosis of the target lesion (%) at 9 months after surgery;The target lesion restenosis rate at 9 months after surgery;The device-oriented composite endpoints (DoCE) at 1 month, 6 months, 9 months and 12 months after surgery;The patient-oriented composite endpoints (PoCE) at 1 month, 6 months, 9 months and 12 months after surgery;The rates of definite and possible thrombosis at 1 month, 6 months, 9 months and 12 months after surgery; | — |
Countries
China
Contacts
Public ContactJiang Jun
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed