Coronary Extension Catheter in PCI for CAD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm study enrolling about 69 adults to receive a coronary extension catheter during percutaneous coronary intervention. The goal is to evaluate safety and effectiveness of the catheter when used to facilitate PCI. Endpoints related to success of the procedure and any adverse events will be collected during treatment and at follow-up. The study is sponsored by BrosMed Medical and conducted at Beijing Friendship Hospital, Capital Medical University in Beijing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Friendship Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Sone, PhD
• Email: songxiantao0929@qq.com
• Phone: 010-63198850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.