Severely Calcified Coronary Lesions
Conditions
Interventions
Intervention group:The coronary atherectomy system (Hunan Eptor Medical Devices Co., LTD.) was used for the pretreatment of coronary artery calcification lesions
Control group:The Rotablator grinding system (from Boston Scientific Corporation) was used for the pre-treatment of coronary artery calcified lesions.
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–80 years; 2.Patients with coronary atherosclerotic heart disease scheduled for PCI; 3.Only one target lesion requires rotational atherectomy; 4.Target lesion is a de novo lesion with a reference vessel diameter between 2.0 and 4.0 mm (by visual estimation); 5.Target lesion length =70% (by visual estimation);or 50% =16 atm); (4)Intravascular ultrasound (IVUS): intimal calcification >=270°; 8.Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Non-imaging Exclusion Criteria (1) Use of any other rotational atherectomy catheter, laser ablation catheter, or shockwave catheter to pretreat the target lesion before the investigational device; (2) Acute myocardial infarction within 2 weeks; (3) Stroke within 3 months (excluding transient ischemic attack and lacunar infarction); (4) Active peptic ulcer or gastrointestinal bleeding within 3 months; (5) Severe heart failure (defined as NYHA/Killip class III/IV or LVEF =178 µmol/L (2 mg/dL) or currently on hemodialysis; (7) Severe allergy or contraindication to antiplatelet, anticoagulant medications, or contrast agents; (8) Psychiatric disorder or history of psychiatric illness resulting in inability to cooperate voluntarily; (9) Lactating, pregnant, or women of childbearing potential planning pregnancy; (10) Currently participating in another interventional clinical trial; (11) Unsuitable for enrollment as judged by the investigator. 2.Imaging Exclusion Criteria (1) More than 2 non-target lesions treated during the index procedure; (2) Distance between the treated non-target lesion and the target lesion =50%); (4) Target lesion located within or involving the ostium of the right coronary artery within 5 mm; (5) Target lesion is an in-stent restenosis lesion; (6) Target lesion involves a bifurcation with a side branch vessel diameter >2.5 mm requiring stent implantation; (7) Presence of an aneurysm or previously implanted stent within 10 mm proximal or distal to the target lesion; (8) Target lesion located in a saphenous vein graft or distal to an arterial graft anastomosis; (9) Target lesion angulation >60°; (10) Angiographic evidence of thrombus in the target vessel; (11) Presence of type C–F dissection or perforation in the target vessel before use of the investigational device; (12) Target lesion that cannot be crossed by a guidewire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural success;Freedom from MACE within 30 days after the procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success;Angiographic success;Incidence of severe intra-procedural vascular complications;Incidence of clinically driven target lesion revascularization (CD-TLR) within 30 days;Incidence of adverse events;Incidence of serious adverse events;Incidence of device deficiencies; | — |
Countries
China
Contacts
Public ContactSun Yingxian
The First Affiliated Hospital of China Medical University
Outcome results
None listed