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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT03405506
Eligibility Criteria:
Inclusion Criteria:
* General inclusion Criteria:
1. Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI;
2. Age \> 18 years;
3. Able to provide signed informed consent.
* Angiographic inclusion criteria:
1. At least two localized lesions on the same coronary artery;
2. More than 50% diameter stenosis (DS) estimated by QCA on each lesion;
3. At least 10 mm relatively normal lumen (at most 20% DS) between two lesions;
4. Reference vessel size \> 2 mm in stenotic segment by visual estimate.
Exclusion Criteria:
* General exclusion criteria:
1. Ineligible for diagnostic intervention or FFR examination;
2. Myocardial infarction within 72 hours;
3. Severe heart failure (NYHA≥III);
4. S-creatinine\>150µmol/L or GFR\<45 ml/kg/1.73m2;
5. Allergy to contrast agent or adenosine;
6. Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation;
7. Serious complications:
1. Evidence of cardiac rupture;
2. History of bleeding (intracranial hemorrhage, gastrointestinal bleeding, etc.);
3. Acute or chronic blood system diseases, including hemoglobin \< 10 g / L, or platelet count \< 50 × 109 / L;
4. Accompanied by other diseases might inducing life expectancy shorter than several months;
5. History of severe renal insufficiency and hypohepatia (liver failure, cirrhosis, portal hypertension and active hepatitis)
6. Aneurysm, arterial / venous malformation, aortic dissection;
8. Cardiogenic shock or circulation capacity failure;
9. Two-degree and more severe atrioventricular block, with no permanent pacemaker implanted;
10. Pregnancy or lactation;
11. The investigators believe that the treatment regimen may be detrimental to the patient or the enrollment of this subject may affect the specific assessment of the trial;
* Angiographic exclusion criteria:
1. The interrogated stenosis is caused by myocardial bridge;
2. Ostial lesions less than 3 mm to the aorta;
3. Side branches of the bifurcation lesions with Median Classification of 111 or 101;
4. Severe overlap or shorten of stenosis segment;
5. Severe tortuosity of target vessel;
6. Poor angiographic image quality precluding contour detection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03405506
Study Brief:
Protocol Section:
NCT03405506