Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions

BrosMed Medical

Status: Completed

Conditions: Coronary Artery Disease; Peripheral Arterial Disease

Treatments: Device: microcatheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05747287

S02

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old;
2. Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
3. 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;
4. 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Device: microcatheter