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

Last updated: January 17, 2024
Sponsor: BrosMed Medical Co., Ltd
Overall Status: Completed

Phase

N/A

Condition

Coronary Artery Disease

Heart Disease

Circulation Disorders

Treatment

microcatheter

Clinical Study ID

NCT05747287
S02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old;
  2. Patients with symptomatic ischemic heart disease who are suitable for non-acutepercutaneous coronary intervention (PCI);
  3. Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronarychronic total occlusion (CTO), or tortuous lesions, who plan to use PronaviMicrocatheter;
  4. Patients or their guardians who understand the purpose of the trial, voluntarilyparticipate and sign the written informed consent, and are able to be followed up.

Exclusion

Exclusion Criteria:

  1. Patients with clinical symptoms consistent with ST-elevation myocardial infarctionand/or ECG changes within 12 hours before the procedure;
  2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrastmedia;
  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.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: microcatheter
Phase:
Study Start date:
January 17, 2023
Estimated Completion Date:
December 22, 2023

Connect with a study center

  • The Shijiazhuang People's Hospital

    Shijiazhuang, Hebei
    China

    Site Not Available

  • The Seventh People's Hospital of Zhengzhou

    Zhengzhou, Henan
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi
    China

    Site Not Available

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