Clinical trial NCT05998252: Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
Official title: A Post-Market Study to Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: BrosMed Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old, gender is not limited;
2. Patients with symptomatic ischemic heart disease who are suitable for percutaneous coronary intervention (PCI);
3. Patients with target lesion diameter stenosis ≥ 70% (visually) or chronic total occlusion (CTO) who needed balloon dilatation catheter pre-dilatation;
4. 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 Criteria:

1. Patients with clinical symptoms consistent with ST-segment elevation myocardial infarction or/and ECG changes within 12 hours prior to the procedure;
2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
3. Patients with in-stent restenosis;
4. Patients with unprotected left main coronary artery disease;
5. Patients who plan to treat 3 or more lesions at the same time;
6. Patients with severe calcified lesions;
7. Patients in whom the guidewire cannot pass through the lesion;
8. Women who are pregnant or lactating;
9. Patients who are participating in the clinical trial of other drugs or medical devices;
10. Other patients considered by the investigator to be unsuitable for this trial.

Primary outcomes:
measure: Procedural Success Rate
timeFrame: 7 days
Secondary outcomes:
measure: Device Success Rate
timeFrame: 0 day
measure: Device Performance Evaluation
timeFrame: 0 day
Other outcomes:
measure: Incidence of major adverse cardiac events (MACE) during the study.
timeFrame: 0 - 7 days
measure: Adverse events and serious adverse events rate
timeFrame: 0 - 7 days
measure: Other Adverse events and serious adverse events rate
timeFrame: 0 - 7 days
Locations:
city: Zhenzhou
country: China
facility: The Seventh People's Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University Hubei General Hospital
state: Hubei
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
Study officials:
References: