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

Launched by BROSMED MEDICAL CO., LTD · Feb 17, 2023

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.