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Study for accuracy of CCTA derived CoronaryScope Fractional flow reserve in diagnosis of coronary artery stenosis

Study for accuracy of CCTA derived CoronaryScope Fractional flow reserve in diagnosis of coronary artery stenosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026971
Enrollment
Unknown
Registered
2019-10-27
Start date
2019-11-15
Completion date
Unknown
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHD

Interventions

Index test:CoronaryScope&#32
CT&#32
Flow&#32
Reserve

Sponsors

FUWAI HOSPITAL,CAMS&PUMC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Able to provide signed informed consent; 3. Patients have at least one suspected stenosis of coronary artery and are planning to undergo PCI surgery. CCTA inclusion criteria: 1. 64-detector row CT scanners or higher; 2. CCTA image should have a high quality and can visualize stenosis in a clear way; 3. At least one stenosis with diameter stenosis of 30%-90% by visual estimate; 4. Reference vessel size > 2 mm in stenotic segment by visual estimate.

Exclusion criteria

Exclusion criteria: General Exclusion Criteria: 1. pregnant or breastfeeding women or on planning; 2. acute myocardial infarction occurs in 30 days ahead of CCTA scan; 3. patients who underwent CABG, PCI, ICD or TAVI surgeries before; 4. Allergy to contrast agent or adenosine; 5. Hypertrophic obstructive cardiomyopathy or Severe heart failure (NYHA>=III); 6. BMI>35kg/m2; 7. S-creatinine>178umol/L; 8. Ineligible for diagnostic intervention or FFR examination. CCTA exclusion criteria: 1. Poor angiographic image quality precluding contour detection; 2. Chronic Total Occlusion of target vessel; 3. The interrogated stenosis is caused by aneurysm or myocardial bridge; CAG exclusion criteria: 1. Severe tortuosity of target vessel.

Design outcomes

Primary

MeasureTime frame
Fractional Flow Reserve Result of surgical examination;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactYida Tang

Fuwai Hospital, Chinese Academy of Medical Sciences

tangyida@fuwaihospital.org+86 010-88398866

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026