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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years old;
- Patients with symptomatic ischemic heart disease who are suitable for non-acutepercutaneous coronary intervention (PCI);
- Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronarychronic total occlusion (CTO), or tortuous lesions, who plan to use PronaviMicrocatheter;
- 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:
- Patients with clinical symptoms consistent with ST-elevation myocardial infarctionand/or ECG changes within 12 hours before the procedure;
- Patients who are known to be intolerant to antiplatelet drugs or allergic to contrastmedia;
- 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.
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
ChinaSite Not Available
The Seventh People's Hospital of Zhengzhou
Zhengzhou, Henan
ChinaSite Not Available
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
ChinaSite Not Available
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