Coronary Artery DiseaseFORTRESSNCT03405506
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by Pulse Medical Imaging Technology (Shanghai) Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia
- What is being tested?
- Quantitative Flow Ratio (QFR)
- Type of treatment
- Medical device
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2017to 20 Jul 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary tandem lesions admitted for coronary angiography due to high risk of significant coronary stenosis
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
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.
Read the 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
- Being tested
- Quantitative Flow Ratio (QFR)
- Keywords
- Fractional Flow Reserve, Quantitative Coronary Angiography, Coronary artery disease, Quantitative Flow Ratio, Tandem lesion, Virtual stenting
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Arterial Occlusive Diseases, Heart Diseases, Vascular Diseases, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Flow Ratio (QFR)Device
FFR measured by pressure wire, QFR computed by coronary angiographic images
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of QFR in tandem lesions as compared with FFR prior to intervention
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)
Measured: 1 hour
Secondary outcomes (1)
Diagnostic accuracy of QFR-based virtual stenting in predicting FFR values after revascularizing the culprit lesion
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)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start13 Jun 2017
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405506
- Sponsor's protocol ID
- CARDIAC201701
- Acronym
- FORTRESS
- Status last verified
- May 2025
- First submitted
- 12 Jan 2018
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.
PubMed 27712739
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
- ClinicalTrials.gov ID
- NCT03405506
- Acronym / sponsor ID
- FORTRESS / CARDIAC201701
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Arterial Occlusive Diseases, Heart Diseases, Vascular Diseases
- Keywords
- Fractional Flow Reserve, Quantitative Coronary Angiography, Coronary artery disease, Quantitative Flow Ratio, Tandem lesion, Virtual stenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary tandem lesions admitted for coronary angiography due to high risk of significant coronary stenosis
Key inclusion criteria (9 listed)
- General inclusion Criteria:
- Angiographic inclusion criteria:
Key exclusion criteria (25 listed)
- General exclusion criteria:
- Angiographic exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Flow Ratio (QFR)FFR measured by pressure wire, QFR computed by coronary angiographic images | Device | – |
Primary outcome
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)
1 secondary outcome
Diagnostic accuracy of QFR-based virtual stenting in predicting FFR values after revascularizing the culprit lesion
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 27712739Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by Pulse Medical Imaging Technology (Shanghai) Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of QFR in tandem lesions as compared with FFR prior to intervention (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.