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Clinical Study of Coronary Extension Catheter

Clinical Study of Coronary Extension Catheter

Recruiting
18 years and older
All
Phase N/A

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Overview

This prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters. The safety and efficacy of these catheters in percutaneous coronary intervention will be assessed through the collection and analysis of efficacy and safety endpoints during treatment and follow-up.

Eligibility

Inclusion Criteria:

  • Age ≥18 years, regardless of gender;
  • Patients suitable for percutaneous coronary intervention (PCI) and for whom the use of an extension catheter is planned to assist the intervention;
  • Ability to understand the purpose of the study, willingness to voluntarily participate, and ability to provide written informed consent.

Exclusion Criteria:

  • Reference vessel diameter \< 2 mm;
  • Presence of thrombus in the target vessel;
  • Unprotected left main coronary artery disease;
  • Acute myocardial infarction occurring within 7 days prior to enrollment;
  • Known intolerance to anticoagulant or antiplatelet therapy, or known allergy to contrast media;
  • Concurrent severe hepatic or renal disease, or other severe systemic conditions that render the patient unsuitable for PCI;
  • Pregnant or lactating women;
  • Currently participating in another clinical trial of a drug or medical device without having reached the primary endpoint or completed the trial;
  • Any other condition that, in the investigator's opinion, makes the patient ineligible for participation in this study.

Study details
    Coronary Artery Disease (CAD)
    Percutaneous Coronary Intervention (PCI)

NCT07742345

BrosMed Medical Co., Ltd

8 August 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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