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

NCT ID: NCT05998252

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-27
• Study Completion Date: 2023-12-08

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alveo 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.

Group Type: EXPERIMENTAL

Alveo HP Balloon Dilatation Catheter

Intervention Type: DEVICE

Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.

Interventions

Alveo HP Balloon Dilatation Catheter

Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrosMed Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Seventh People's Hospital of Zhengzhou

Zhenzhou, Henan, China

Renmin Hospital of Wuhan University Hubei General Hospital

Wuhan, Hubei, China

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Countries

China

Other Identifiers

S01

Identifier Type: -

Identifier Source: org_study_id