Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting (FORTRESS)
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|ClinicalTrials.gov Identifier: NCT03405506|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Cardiovascular Diseases Myocardial Ischemia Arterial Occlusive Diseases Heart Diseases Vascular Diseases Arteriosclerosis||Device: Quantitative Flow Ratio (QFR)|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||69 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting|
|Estimated Study Start Date :||February 2, 2018|
|Estimated Primary Completion Date :||February 2, 2019|
|Estimated Study Completion Date :||February 2, 2019|
- Device: Quantitative Flow Ratio (QFR)
FFR measured by pressure wire, QFR computed by coronary angiographic images
- Diagnostic accuracy of QFR in tandem lesions as compared with FFR prior to intervention [ Time Frame: 1 hour ]Diagnostic accuracy was defined as the concordance ratio of QFR evaluated outcomes (≤ 0.8 or > 0.8) with the reference standard FFR evaluated outcomes (≤ 0.8 or > 0.8)
- Diagnostic accuracy of QFR-based virtual stenting in predicting FFR values after revascularizing the culprit lesion [ Time Frame: 1 hour ]Diagnostic accuracy was defined as the concordance ratio of QFR evaluated outcomes (≤ 0.8 or > 0.8) with the reference standard FFR evaluated outcomes (≤ 0.8 or > 0.8)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405506
|Contact: Shaofeng Guanfirstname.lastname@example.org|
|Shanghai Chest Hospital||Not yet recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Shaofeng Guan|