Status:
COMPLETED
Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
Lead Sponsor:
BrosMed Medical Co., Ltd
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilatio...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old, gender is not limited;
- Patients with symptomatic ischemic heart disease who are suitable for percutaneous coronary intervention (PCI);
- Patients with target lesion diameter stenosis ≥ 70% (visually) or chronic total occlusion (CTO) who needed balloon dilatation catheter pre-dilatation;
- Patients or their guardians who can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can accept follow-up;
Exclusion
- Patients with clinical symptoms consistent with ST-segment elevation myocardial infarction or/and ECG changes within 12 hours prior to the procedure;
- Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
- Patients with in-stent restenosis;
- Patients with unprotected left main coronary artery disease;
- Patients who plan to treat 3 or more lesions at the same time;
- Patients with severe calcified lesions;
- Patients in whom the guidewire cannot pass through the lesion;
- Women who are pregnant or lactating;
- Patients who are participating in the clinical trial of other drugs or medical devices;
- Other patients considered by the investigator to be unsuitable for this trial.
Key Trial Info
Start Date :
December 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05998252
Start Date
December 27 2022
End Date
December 8 2023
Last Update
January 10 2024
Active Locations (3)
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1
The Seventh People's Hospital of Zhengzhou
Zhenzhou, Henan, China
2
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
3
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China