Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT06649305
Eligibility Criteria:
Inclusion Criteria:
* 1: Aged 18-80 years, gender is not limited
2: Patients with diabetes who require interventional therapy (diabetes definition: active treatment with insulin or oral hypoglycemic agents at admission). For patients with diabetes who are treated with diet only, abnormal fasting blood sugar (\>7 mmol/l), blood sugar \>11.1 mmol/l at any time, or abnormal glucose tolerance tests based on World Health Organization standards need to be recorded.
3: Endoscopic imaging examination or interventional therapy under the guidance of endoscopic imaging is required
4: Be able to understand the purpose of clinical research, voluntarily participate can complete the observation as required and sign the informed consent form
5: At least 2 coronary arteries (including suspected criminal coronary arteries) are suitable for NIRS-OCT imaging
6: Stenosis with non-target lesions \> 50%
Exclusion Criteria:
* 1: Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)
2: Severe hemodynamic disorder or shock that cannot be corrected
3: Patients with renal impairment（eGFR\<30 mL/min/1.73m2）
4: Severe symptoms of heart failure (NYHA III and above) or left ventricular ejection fraction \<30%
5: The presence or suspected presence of infective endocarditis or systemic active infection
6: Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study
7: Patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months
8: Pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures
9: The target vessel has severe calcification or severe tortuosity, which cannot be examined by OCT
10: Have participated in other clinical trials or are participating in other drug/device clinical trials within 3 months prior to enrollment and have not met the primary endpoint
11: Investigators believe that those who are unnecessary for OCT or not suitable for inclusion in this trial.
12: There are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06649305
Study Brief:
Protocol Section:
NCT06649305