Coronary Artery Disease
Conditions
Interventions
Experimental group:Use of the Trapping Balloon Catheter during the procedure to trap the guidewire within the guiding catheter via balloon inflation, to facilitate device exchange
Sponsors
Shanxi Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, with no gender restriction; 2. Diagnosed with coronary artery disease and scheduled for percutaneous coronary intervention (PCI); 3. Requiring the use of the Trapping Balloon Catheter to assist with device exchange during the procedure; 4. Signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Unprotected left main disease; 2. Known severe allergy or contraindication to contrast media, anesthetics, or any components of the investigational device; 3. Pregnant or lactating women; 4. Currently participating in another drug or medical device clinical trial; 5. Considered unsuitable for enrollment in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Incidence of adverse events;Incidence of serious adverse events;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactWang Jingping
Shanxi Cardiovascular Hospital
Outcome results
None listed