Status:
COMPLETED
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
Lead Sponsor:
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Collaborating Sponsors:
Shanghai Chest Hospital
Conditions:
Coronary Artery Disease
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predic...
Detailed Description
QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel. 3D coronary models can be reconstructed based on two angiograph...
Eligibility Criteria
Inclusion
- General inclusion Criteria:
- Stable and unstable angina pectoris or secondary evaluation of stenosis after acute 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
- 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 than several 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 pacemaker implanted;
- Pregnancy or lactation;
- 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:
- 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.
Key Trial Info
Start Date :
June 13 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 20 2017
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT03405506
Start Date
June 13 2017
End Date
July 20 2017
Last Update
June 3 2025
Active Locations (1)
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1
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040