A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions

BrosMed Medical Co., Ltd3 sites in 1 country60 target enrollmentJanuary 17, 2023

ConditionsCoronary Artery Disease Peripheral Arterial Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: BrosMed Medical Co., Ltd
Enrollment: 60
Locations: 3
Primary Endpoint: Technical success
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.

Registry

clinicaltrials.gov

Start Date

January 17, 2023

End Date

December 22, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BrosMed Medical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old;
•Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
•Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (CTO), or tortuous lesions, who plan to use Pronavi Microcatheter;
•Patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up.

Exclusion Criteria

•Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure;
•Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
•Patients with in-stent occlusion;
•Patients with unprotected left main coronary artery disease;
•Women who are pregnant or lactating;
•Patients who are participating in clinical trials of other drugs or medical devices;
•Patients with contraindications to the investigational device;
•Other patients considered by the investigators to be unsuitable for this trial.

Outcomes

Primary Outcomes

Technical success

Time Frame: 0 day

Defined as successful guide wire passage, that is, the Pronavi Microcatheter successfully supports the guide wire through the target lesion to reach the distal true coelom.