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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
Sponsor:
Collaborator:
Shanghai Chest Hospital
Information provided by (Responsible Party):
Pulse Medical Imaging Technology (Shanghai) Co., Ltd

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 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)

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 Type : Observational [Patient Registry]
Estimated Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Device: Quantitative Flow Ratio (QFR)
    FFR measured by pressure wire, QFR computed by coronary angiographic images


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary tandem lesions admitted for coronary angiography due to high risk of significant coronary stenosis
Criteria

Inclusion Criteria:

  • General inclusion Criteria:

    1. Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI;
    2. Age > 18 years;
    3. Able to provide signed informed consent.
  • Angiographic inclusion criteria:

    1. At least two localized lesions on the same coronary artery;
    2. More than 50% diameter stenosis (DS) estimated by QCA on each lesion;
    3. At least 10 mm relatively normal lumen (at most 20% DS) between two lesions;
    4. Reference vessel size > 2 mm in stenotic segment by visual estimate.

Exclusion Criteria:

  • General exclusion criteria:

    1. Ineligible for diagnostic intervention or FFR examination;
    2. Myocardial infarction within 72 hours;
    3. Severe heart failure (NYHA≥III);
    4. S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2;
    5. Allergy to contrast agent or adenosine;
    6. Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation;
    7. Serious complications:

      1. Evidence of cardiac rupture;
      2. History of bleeding (intracranial hemorrhage, gastrointestinal bleeding, etc.);
      3. Acute or chronic blood system diseases, including hemoglobin < 10 g / L, or platelet count < 50 × 109 / L;
      4. Accompanied by other diseases might inducing life expectancy shorter than several months;
      5. History of severe renal insufficiency and hypohepatia (liver failure, cirrhosis, portal hypertension and active hepatitis)
      6. Aneurysm, arterial / venous malformation, aortic dissection;
    8. Cardiogenic shock or circulation capacity failure;
    9. Two-degree and more severe atrioventricular block, with no permanent pacemaker implanted;
    10. Pregnancy or lactation;
    11. 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:

    1. The interrogated stenosis is caused by myocardial bridge;
    2. Ostial lesions less than 3 mm to the aorta;
    3. Side branches of the bifurcation lesions with Median Classification of 111 or 101;
    4. Severe overlap or shorten of stenosis segment;
    5. Severe tortuosity of target vessel;
    6. Poor angiographic image quality precluding contour detection.

Information from the National Library of Medicine

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


Contacts
Contact: Shaofeng Guan 13386077063 gsf@qq.com

Locations
China, Shanghai
Shanghai Chest Hospital Not yet recruiting
Shanghai, Shanghai, China, 200030
Contact: Shaofeng Guan         
Sponsors and Collaborators
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Shanghai Chest Hospital

Publications:
Responsible Party: Pulse Medical Imaging Technology (Shanghai) Co., Ltd
ClinicalTrials.gov Identifier: NCT03405506     History of Changes
Other Study ID Numbers: CARDIAC201701
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pulse Medical Imaging Technology (Shanghai) Co., Ltd:
Fractional Flow Reserve
Quantitative Coronary Angiography
Coronary artery disease
Quantitative Flow Ratio
Tandem lesion
Virtual stenting

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes