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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05998252
• Other study ID #: S01
• Status: Completed
• Phase: N/A
• Start date: December 27, 2022
• Est. completion date: December 8, 2023

Study information

• Verified date: January 2024
• Source: BrosMed Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 8, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Stenosis

Intervention

Device:
• Alveo HP Balloon Dilatation Catheter
Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.

Locations

Country	Name	City	State
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	Renmin Hospital of Wuhan University Hubei General Hospital	Wuhan	Hubei
China	The Seventh People's Hospital of Zhengzhou	Zhenzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
BrosMed Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of major adverse cardiac events (MACE) during the study.	Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).	0 - 7 days
Other	Adverse events and serious adverse events rate	Adverse events and serious adverse events related to the study device during the study.	0 - 7 days
Other	Other Adverse events and serious adverse events rate	Occurrence of other adverse events and serious adverse events	0 - 7 days
Primary	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	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
Secondary	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