Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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A Post-Market Study to Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Alveo HP Balloon Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old, gender is not limited; Patients with symptomatic ischemic heart disease who are suitable for percutaneous coronary intervention (PCI); Patients with target lesion diameter stenosis ≥ 70% (visually) or chronic total occlusion (CTO) who needed balloon dilatation catheter pre-dilatation; 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: Patients with clinical symptoms consistent with ST-segment elevation myocardial infarction or/and ECG changes within 12 hours prior to the procedure; Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media; Patients with in-stent restenosis; Patients with unprotected left main coronary artery disease; Patients who plan to treat 3 or more lesions at the same time; Patients with severe calcified lesions; Patients in whom the guidewire cannot pass through the lesion; Women who are pregnant or lactating; Patients who are participating in the clinical trial of other drugs or medical devices; Other patients considered by the investigator to be unsuitable for this trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alveo balloon dilatation catheter<br>Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with Alveo balloon dilatation catheter. | Device: Alveo HP Balloon Dilatation Catheter<br>* Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success Rate | Defined as meeting all the following criteria: After PCI, the target lesion achieves a final diameter stenosis of ≤30%, and the TIMI grade of 3; 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success Rate | Defined as meeting all the following criteria: Successful delivery to the target location, completely pre-dilatation and successful withdrawal by using Alveo HP Balloon Dilatation Catheter; No evidence of arterial perforation, flow-restricted dissection, decreased TIMI grade while using the device, or no clinically significant arrhythmias after pre-dilatation. | 0 day | 
| Device Performance Evaluation | 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. | 0 day |