Trials / Completed
CompletedNCT03405506
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 308 (actual)
- Sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 predict the functional significance of coronary stenosis as if the stenosis was revascularized. The purpose of this study is to evaluate the diagnostic accuracy of QFR in in tandem lesions with fractional flow reserve (FFR) as the reference standard. The secondary purpose is to evaluate the diagnostic accuracy of QFR-based virtual stent technique in predicting the FFR values after revascularizing the culprit lesion.
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 angiographic projections to obtain the geometric parameters, including vascular diameter or cross-sectional area. According to the lesion stenosis, vessel curvature, conical geometry and reference lumen characteristics, pressure drop can be calculated in real time based on its relationship with blood flow. There is no need for pressure wire and adenosine / ATP induced maximum hyperemia compared with FFR. The FAVOR Pilot Study and FAVOR II China Study showed promising results for diagnostic accuracy in consecutive patients. However, the diagnostic accuracy of QFR in specific tandem lesions needs further investigation. Furthermore, using the virtual stent technology to accurately assess the culprit lesion and choose the optimal treatment is significant in precisely guiding PCI surgery.
Conditions
- Coronary Artery Disease
- Cardiovascular Diseases
- Myocardial Ischemia
- Arterial Occlusive Diseases
- Heart Diseases
- Vascular Diseases
- Arteriosclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Quantitative Flow Ratio (QFR) | FFR measured by pressure wire, QFR computed by coronary angiographic images |
Timeline
- Start date
- 2017-06-13
- Primary completion
- 2017-07-20
- Completion
- 2017-07-20
- First posted
- 2018-01-23
- Last updated
- 2025-06-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03405506. Inclusion in this directory is not an endorsement.