CAD
Conditions
Interventions
Trial group:Cardiovascular three-dimensional optical coherence imaging system and optical scanning imaging catheter
Control group:Optical coherent tomography imaging system and imaging catheter
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years, male or non-pregnant female; 2. Patients who require percutaneous coronary stent implantation, with only one stent implanted in each target vessel; 3. The luminal diameter of the stented vessel segment is between 2.0 and 3.5 mm; 4. Willing not to participate in any other clinical trial before reaching the endpoint of this study; 5. Able to understand the purpose of the clinical trial, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with left main coronary artery lesions or injury at the coronary ostium; 2. Patients with a large intracoronary thrombus, or severe calcification or marked tortuosity of the target vessel; 3. Patients with acute coronary syndrome within 24 hours; 4. Patients whose target vessel has undergone coronary artery bypass grafting; 5. Patients with New York Heart Association (NYHA) Class III or IV heart failure; 6. Patients with preoperative renal impairment, defined as serum creatinine >2.0 mg/dL, or those receiving hemodialysis; 7. Patients with unstable arrhythmias, such as high-risk premature ventricular contractions or ventricular tachycardia; 8. Patients with platelet count 700×10?/L, or white blood cell count <3×10?/L, as indicated by routine blood testing; 9. Patients who have undergone solid organ transplantation or are awaiting organ transplantation; 10. Patients who participated in another drug or medical device clinical trial prior to enrollment and had not yet reached the primary endpoint assessment timepoint of that trial; 11. Patients judged by the investigator to have poor compliance and be unable to complete the clinical trial as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clear stent length; | — |
Secondary
| Measure | Time frame |
|---|---|
| The clear image length;Adverse events related/possibly related to the study device; | — |
Countries
China
Contacts
Public ContactChen Yundai
the General Hospital of the People's Liberation Army
Outcome results
None listed