Coronary heart disease
Conditions
Interventions
Trial group:Coronary cutting balloon
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years; 2. Patients with coronary atherosclerotic heart disease scheduled for PCI; 3. This procedure involves intervention of at most two lesions in different vessels, one being the target lesion (using the test device) and the other a non-target lesion; 4. Target lesion or target vessel: (1) Lesion type meets any of the following: 1) In-stent restenosis; 2) Ostial lesion: lesion within 3 mm from the vessel ostium, including aortic and branch vessel ostia; 3) Bifurcation lesion; 4) Mild calcification: during angiography, a faint and blurry high-density shadow is visible only during cardiac contraction, and no calcification is visible when the heart is not contracting; 5) Moderate calcification: during angiography, a clearer and more easily visible high-density shadow is observed during cardiac contraction; 6) Severe calcification lesion pre-treated with rotational atherectomy or shockwave therapy, where severe calcification is defined as: during angiography, a clear high-density shadow is visible both during and without cardiac contraction; 7) Lesion inadequately dilated by a conventional balloon, where inadequate dilation is defined as: post-dilation visual residual stenosis >50%; (2) Reference vessel diameter between 2.0 and 4.0 mm (visual estimation); (3) Lesion length =70% (visual estimation); or 50% <= diameter stenosis <70% (visual estimation) with evidence of myocardial ischemia; (5) TIMI flow grade 3 prior to use of the test device. 5. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria—Non-imaging (1) Simultaneous use of any other pressure-focused balloon for target lesion treatment: e.g., cutting balloon, double-wire balloon, scoring balloon, protruding balloon, or other similar balloons; (2) Acute myocardial infarction within the past 2 weeks; (3) Stroke within the past 3 months, excluding transient ischemic attack (TIA) or lacunar infarction; (4) History of active peptic ulcer or active gastrointestinal bleeding within the past 3 months; (5) NYHA heart function class III/IV or left ventricular ejection fraction (LVEF) 221 µmol/L or currently undergoing hemodialysis; (7) Severe allergy or contraindication to antiplatelet agents, anticoagulants, or contrast media; (8) Patients who cannot undergo coronary artery bypass grafting (CABG) surgery in an emergency situation; (9) Planned elective surgery within 1 month requiring discontinuation of antiplatelet or anticoagulant therapy; (10) Dementia, psychiatric abnormalities, or history of psychiatric illness preventing autonomous cooperation; (11) Lactation, pregnancy, or planned pregnancy during the study period; (12) Currently participating in another interventional clinical trial; (13) Ineligible for this trial as determined by the investigator. 2. Exclusion Criteria—Imaging (1) Intended intervention on unprotected left main coronary artery lesion; (2) The following apply only to the target lesion or target vessel: 1) Lesion in a bypass graft; 2) Stent fracture lesion; 3) Branch vessel lesion covered by a stent; 4) Branch vessel diameter >=2.5 mm in a bifurcation lesion; 5) Severe proximal vessel tortuosity; 6) Lesion angulation >=45°; 7) Lesion impassable by guidewire or balloon; 8) Flow-limiting dissection (NHLBI type C or higher) or perforation in the target vessel prior to use of the investigational device; 9) Thrombus confirmed in the target vessel by angiography.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural success rate;MACE-free rate within 14 days after the procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Incidence of Target Lesion Failure (TLF) within 30 days post-surgery;Adverse Event rate;Serious Adverse Event rate;Lesion preparation success rate ;Serious device-related vascular complications rate;Acute lumen diameter gain; | — |
Countries
China
Contacts
Public ContactLi Yan
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed