A Post-Market Study to Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- BrosMed Medical Co., Ltd
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Procedural Success Rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Procedural Success Rate
Time Frame: 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 Outcomes
- Device Performance Evaluation(0 day)
- Device Success Rate(0 day)