Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Alveo HP Balloon Dilatation Catheter
- Registration Number
- NCT05998252
- Lead Sponsor
- BrosMed Medical Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Alveo balloon dilatation catheter Alveo HP Balloon Dilatation Catheter 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (3)
Shanxi Cardiovascular Hospital
🇨🇳Taiyuan, Shanxi, China
The Seventh People's Hospital of Zhengzhou
🇨🇳Zhenzhou, Henan, China
Renmin Hospital of Wuhan University Hubei General Hospital
🇨🇳Wuhan, Hubei, China