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

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Alveo HP Balloon Dilatation Catheter

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhenzhou, Henan, China
      • The Seventh People's Hospital of Zhengzhou
  • Hubei
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University Hubei General Hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Alveo HP Balloon Dilatation Catheter; Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Adverse events and serious adverse events rate	Occurrence of other adverse events and serious adverse events	0 - 7 days

Collaborators and Investigators

• Sponsor: BrosMed Medical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2022
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Artery Disease; Coronary Stenosis; Dilatation, Pathologic
• Other Study ID Numbers: S01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No