Coronary Artery Disease
Conditions
Brief summary
This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.
Interventions
DEVICEAlveo HP Balloon Dilatation Catheter
Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.
Sponsors
BrosMed Medical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old, gender is not limited; 2. Patients with symptomatic ischemic heart disease who are suitable for percutaneous coronary intervention (PCI); 3. Patients with target lesion diameter stenosis ≥ 70% (visually) or chronic total occlusion (CTO) who needed balloon dilatation catheter pre-dilatation; 4. Patients or their guardians who can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can accept follow-up;
Exclusion criteria
1. Patients with clinical symptoms consistent with ST-segment elevation myocardial infarction or/and ECG changes within 12 hours prior to the procedure; 2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media; 3. Patients with in-stent restenosis; 4. Patients with unprotected left main coronary artery disease; 5. Patients who plan to treat 3 or more lesions at the same time; 6. Patients with severe calcified lesions; 7. Patients in whom the guidewire cannot pass through the lesion; 8. Women who are pregnant or lactating; 9. Patients who are participating in the clinical trial of other drugs or medical devices; 10. Other patients considered by the investigator to be unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success Rate | 7 days | Defined as meeting all the following criteria: 1. After PCI, the target lesion achieves a final diameter stenosis of ≤30%, and the TIMI grade of 3; 2. No all-cause mortality, Q-wave myocardial infarction, stroke, cardiac tamponade, or target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) during postoperative follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success Rate | 0 day | Defined as meeting all the following criteria: 1. Successful delivery to the target location, completely pre-dilatation and successful withdrawal by using Alveo HP Balloon Dilatation Catheter; 2. No evidence of arterial perforation, flow-restricted dissection, decreased TIMI grade while using the device, or no clinically significant arrhythmias after pre-dilatation. |
| Device Performance Evaluation | 0 day | The investigators will evaluate the device performance according to the use and operation of the device during the procedure. Evaluate performance of balloon catheter delivery, inflation, deflation, and withdrawal, etc. There are 5 levels ranging from poor to excellent, higher scores indicate better performance. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse cardiac events (MACE) during the study. | 0 - 7 days | Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR). |
| Adverse events and serious adverse events rate | 0 - 7 days | Adverse events and serious adverse events related to the study device during the study. |
| Other Adverse events and serious adverse events rate | 0 - 7 days | Occurrence of other adverse events and serious adverse events |
Countries
China
Outcome results
None listed