Phase
Condition
Vascular Diseases
Thrombosis
Coronary Artery Disease
Treatment
Quantitative Flow Ratio (QFR)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- General inclusion Criteria:
Stable and unstable angina pectoris or secondary evaluation of stenosis afteracute MI;
Age > 18 years;
Able to provide signed informed consent.
- Angiographic inclusion criteria:
At least two localized lesions on the same coronary artery;
More than 50% diameter stenosis (DS) estimated by QCA on each lesion;
At least 10 mm relatively normal lumen (at most 20% DS) between two lesions;
Reference vessel size > 2 mm in stenotic segment by visual estimate.
Exclusion
Exclusion Criteria:
- General exclusion criteria:
Ineligible for diagnostic intervention or FFR examination;
Myocardial infarction within 72 hours;
Severe heart failure (NYHA≥III);
S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2;
Allergy to contrast agent or adenosine;
Factors that might substantially impact the angiographic image quality, e.g,frequent atrial premature beat or atrial fibrillation;
Serious complications:
Evidence of cardiac rupture;
History of bleeding (intracranial hemorrhage, gastrointestinal bleeding,etc.);
Acute or chronic blood system diseases, including hemoglobin < 10 g / L,or platelet count < 50 × 109 / L;
Accompanied by other diseases might inducing life expectancy shorter thanseveral months;
History of severe renal insufficiency and hypohepatia (liver failure,cirrhosis, portal hypertension and active hepatitis)
Aneurysm, arterial / venous malformation, aortic dissection;
Cardiogenic shock or circulation capacity failure;
Two-degree and more severe atrioventricular block, with no permanent pacemakerimplanted;
Pregnancy or lactation;
The investigators believe that the treatment regimen may be detrimental to thepatient or the enrollment of this subject may affect the specific assessment ofthe trial;
- Angiographic exclusion criteria:
The interrogated stenosis is caused by myocardial bridge;
Ostial lesions less than 3 mm to the aorta;
Side branches of the bifurcation lesions with Median Classification of 111 or 101;
Severe overlap or shorten of stenosis segment;
Severe tortuosity of target vessel;
Poor angiographic image quality precluding contour detection.
Study Design
Study Description
Connect with a study center
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai 200040
ChinaSite Not Available
Shanghai Chest Hospital
Shanghai, Shanghai 200030
ChinaSite Not Available

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