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

NCT05998252 | Completed

• 1 other identifier: S01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Procedural Success Rate

  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.

  7 days

Secondary Outcomes (2)

• Device Success Rate

  0 day

• Device Performance Evaluation

  0 day

Other Outcomes (3)

• Incidence of major adverse cardiac events (MACE) during the study.

  0 - 7 days

• Adverse events and serious adverse events rate

  0 - 7 days

• Other Adverse events and serious adverse events rate

  0 - 7 days

Study Arms (1)

Alveo balloon dilatation catheter

EXPERIMENTAL

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

Interventions

Alveo HP Balloon Dilatation Catheter DEVICE

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

Alveo balloon dilatation catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrosMed Medical Co., Ltd: lead

Study Sites (3)

The Seventh People's Hospital of Zhengzhou

Zhenzhou, Henan, China

Location

Renmin Hospital of Wuhan University Hubei General Hospital

Wuhan, Hubei, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: August 18, 2023
• Study Start: December 27, 2022
• Primary Completion: August 29, 2023
• Study Completion: December 8, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)