Clinical Study of Coronary Extension Catheter

NCT07742345 — Not applicable, Recruiting, 69 participants, BrosMed Medical Co., Ltd

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A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention

RegistryNCT07742345
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment69 (Estimated)
SponsorBrosMed Medical Co., Ltd (Industry)
ConditionsCoronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
InterventionsCoronary Extension Catheter (Device)
Datesstart 2026-06-25, primary completion 2027-04-30 (estimated), completion 2027-04-30 (estimated), first posted 2026-08-03, last updated 2026-08-03
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Coronary Artery Disease (CAD) All trials for Percutaneous Coronary Intervention (PCI) All trials of Coronary Extension Catheter

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
test groupExperimentalDevice: Coronary Extension Catheter
  • Coronary Extension Catheter (Device): For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.

+Outcome measures

Primary outcomes

  • Device Delivery Success Rate [Immediately after procedure, 0 day]: Device delivery success is defined as the successful delivery of the target device (balloon and/or stent) to the target lesion after the use of the study device during percutaneous coronary intervention (PCI).

Secondary outcomes

  • Procedural Success Rate [Immediately after procedure, 0 day]: Procedural success is defined as residual stenosis of the target lesion ≤30% (by visual estimation) and TIMI flow grade 3 after PCI.
  • Device Usage Evaluation [Immediately after procedure, 0 day]: The device usage evaluation includes: pushability, support, overall ease of use, device trackability, and radiopacity. There are four grades, ranging from poor to excellent.
  • Adverse events and serious adverse events related to the study device [Endpoints will be measured through hospital discharge (expected to be within 7 days)]: Adverse events and serious adverse events related to the study device during the study.
  • Adverse Event and Serious Adverse Event [Endpoints will be measured through hospital discharge (expected to be within 7 days)]: Occurrence of adverse events and serious adverse events during the study.
  • Device defects [Immediately after procedure, 0 day]: Incidence of device defects.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Beijing Friendship Hospital, Capital Medical UniversityBeijingChinaRecruiting