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

BrosMed Medical

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Alveo HP Balloon Dilatation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05998252

S01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Alveo balloon dilatation catheter

Experimental group

Description:

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.

Treatment:

Device: Alveo HP Balloon Dilatation Catheter