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Completed

NCT Number: NCT05998252

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Seventh People's Hospital of Zhengzhou, Zhenzhou, Henan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

Alveo HP Balloon Dilatation Catheter

Device

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

Primary outcomes

  1. Procedural Success Rate

    Time frame: 7 days

    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.

Secondary outcomes

  1. Device Success Rate

    Time frame: 0 day

    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.

  2. Device Performance Evaluation

    Time frame: 0 day

    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.

Other outcomes

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

    Time frame: 0 - 7 days

    Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).

  2. Adverse events and serious adverse events rate

    Time frame: 0 - 7 days

    Adverse events and serious adverse events related to the study device during the study.

  3. Other Adverse events and serious adverse events rate

    Time frame: 0 - 7 days

    Occurrence of other adverse events and serious adverse events

Sponsors and collaborators

Lead sponsor

BrosMed Medical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2023
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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