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Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty (QIMERA-I)

Primary Purpose

Coronary Occlusion

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Quantitative Flow Ratio (QFR) measurement
Sponsored by
Hospital Clínico Universitario de Valladolid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Occlusion focused on measuring Quantitative Flow Ratio, QFR, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis with PCI indication.

Exclusion Criteria:

  • Severe stenosis of the left main coronary artery.
  • Patients admitted with ST-elevation myocardial infarction.
  • Culprit lesions in Non-ST-Elevation Acute Coronary Syndromes (NSTEACS) patients.
  • Unability to identify the culprit lesion in NSTE-ACS patients.

Sites / Locations

  • Complejo Hospitalario Universitario, Santiago de CompostelaRecruiting
  • Hospital de LugoRecruiting
  • Hospital Clínico San CarlosRecruiting
  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
  • Hospital Clínico Universitario de ValladolidRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QFR Intervention

Arm Description

Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis between 50 and 90% and PCI indication with paired assessment of QFR, dFR, RFR and FFR, before and after PCI once informed consent is provided.

Outcomes

Primary Outcome Measures

Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.

Secondary Outcome Measures

Sensitivity
Specificity
Summary of the receiver-operator characteristics curve (sROC)
Negative predictive value
Positive predictive value
Positive likelihood ratio
Negative likelihood ratio
Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.

Full Information

First Posted
December 13, 2019
Last Updated
September 23, 2021
Sponsor
Hospital Clínico Universitario de Valladolid
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1. Study Identification

Unique Protocol Identification Number
NCT04200469
Brief Title
Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
Acronym
QIMERA-I
Official Title
Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clínico Universitario de Valladolid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective intervention study to assess the accuracy of the predicted QFR-derived virtual angioplasty compared to hyperaemic and non-hyperaemic pressure-wire derived indexes after PCI, as well as with QFR post-PCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusion
Keywords
Quantitative Flow Ratio, QFR, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QFR Intervention
Arm Type
Experimental
Arm Description
Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis between 50 and 90% and PCI indication with paired assessment of QFR, dFR, RFR and FFR, before and after PCI once informed consent is provided.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative Flow Ratio (QFR) measurement
Intervention Description
Quantitative flow ratio (QFR) is a novel approach enabling rapid computation of FFR pullbacks from three-dimensional quantitative coronary angiography (3D-QCA) without using a pressure wire.
Primary Outcome Measure Information:
Title
Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Sensitivity
Time Frame
1 hour
Title
Specificity
Time Frame
1 hour
Title
Summary of the receiver-operator characteristics curve (sROC)
Time Frame
1 hour
Title
Negative predictive value
Time Frame
1 hour
Title
Positive predictive value
Time Frame
1 hour
Title
Positive likelihood ratio
Time Frame
1 hour
Title
Negative likelihood ratio
Time Frame
1 hour
Title
Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis with PCI indication. Exclusion Criteria: Severe stenosis of the left main coronary artery. Patients admitted with ST-elevation myocardial infarction. Culprit lesions in Non-ST-Elevation Acute Coronary Syndromes (NSTEACS) patients. Unability to identify the culprit lesion in NSTE-ACS patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Baladron, PhD
Phone
+34983420000
Email
icicor@icicor.es
Facility Information:
Facility Name
Complejo Hospitalario Universitario, Santiago de Compostela
City
Santiago De Compostela
State/Province
La Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José R Rumoroso, MD
First Name & Middle Initial & Last Name & Degree
Mario Sadaba
Facility Name
Hospital de Lugo
City
Lugo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymundo Ocaranza-Sanchez, PhD, MD
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Escaned, PhD, MD
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Pinar, PhD
First Name & Middle Initial & Last Name & Degree
Ramon López-Palop, PhD, MD
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Baladron, Dr.
Phone
983420000
First Name & Middle Initial & Last Name & Degree
Alfredo Redondo-Diéguez, MD
First Name & Middle Initial & Last Name & Degree
Ignacio J Amat-Santos, PhD, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28356440
Citation
Ahn JM, Park DW, Shin ES, Koo BK, Nam CW, Doh JH, Kim JH, Chae IH, Yoon JH, Her SH, Seung KB, Chung WY, Yoo SY, Lee JB, Choi SW, Park K, Hong TJ, Lee SY, Han M, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ; IRIS-FFR Investigatorsdagger. Fractional Flow Reserve and Cardiac Events in Coronary Artery Disease: Data From a Prospective IRIS-FFR Registry (Interventional Cardiology Research Incooperation Society Fractional Flow Reserve). Circulation. 2017 Jun 6;135(23):2241-2251. doi: 10.1161/CIRCULATIONAHA.116.024433. Epub 2017 Mar 29.
Results Reference
background
PubMed Identifier
9525557
Citation
Bech GJ, De Bruyne B, Bonnier HJ, Bartunek J, Wijns W, Peels K, Heyndrickx GR, Koolen JJ, Pijls NH. Long-term follow-up after deferral of percutaneous transluminal coronary angioplasty of intermediate stenosis on the basis of coronary pressure measurement. J Am Coll Cardiol. 1998 Mar 15;31(4):841-7. doi: 10.1016/s0735-1097(98)00050-3.
Results Reference
background
PubMed Identifier
11413082
Citation
Bech GJ, De Bruyne B, Pijls NH, de Muinck ED, Hoorntje JC, Escaned J, Stella PR, Boersma E, Bartunek J, Koolen JJ, Wijns W. Fractional flow reserve to determine the appropriateness of angioplasty in moderate coronary stenosis: a randomized trial. Circulation. 2001 Jun 19;103(24):2928-34. doi: 10.1161/01.cir.103.24.2928.
Results Reference
background
PubMed Identifier
17531660
Citation
Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.
Results Reference
background
PubMed Identifier
26733607
Citation
Adjedj J, De Bruyne B, Flore V, Di Gioia G, Ferrara A, Pellicano M, Toth GG, Bartunek J, Vanderheyden M, Heyndrickx GR, Wijns W, Barbato E. Significance of Intermediate Values of Fractional Flow Reserve in Patients With Coronary Artery Disease. Circulation. 2016 Feb 2;133(5):502-8. doi: 10.1161/CIRCULATIONAHA.115.018747. Epub 2016 Jan 5.
Results Reference
background
PubMed Identifier
28317458
Citation
Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.
Results Reference
background
PubMed Identifier
28317438
Citation
Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18.
Results Reference
background
PubMed Identifier
30165437
Citation
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.
Results Reference
background
PubMed Identifier
29555835
Citation
Westra J, Tu S, Winther S, Nissen L, Vestergaard MB, Andersen BK, Holck EN, Fox Maule C, Johansen JK, Andreasen LN, Simonsen JK, Zhang Y, Kristensen SD, Maeng M, Kaltoft A, Terkelsen CJ, Krusell LR, Jakobsen L, Reiber JHC, Lassen JF, Bottcher M, Botker HE, Christiansen EH, Holm NR. Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). Circ Cardiovasc Imaging. 2018 Mar;11(3):e007107. doi: 10.1161/CIRCIMAGING.117.007107.
Results Reference
background
PubMed Identifier
28642995
Citation
van Rosendael AR, Koning G, Dimitriu-Leen AC, Smit JM, Montero-Cabezas JM, van der Kley F, Jukema JW, Reiber JHC, Bax JJ, Scholte AJHA. Accuracy and reproducibility of fast fractional flow reserve computation from invasive coronary angiography. Int J Cardiovasc Imaging. 2017 Sep;33(9):1305-1312. doi: 10.1007/s10554-017-1190-3. Epub 2017 Jun 22.
Results Reference
background
PubMed Identifier
28331135
Citation
Yazaki K, Otsuka M, Kataoka S, Kahata M, Kumagai A, Inoue K, Koganei H, Enta K, Ishii Y. Applicability of 3-Dimensional Quantitative Coronary Angiography-Derived Computed Fractional Flow Reserve for Intermediate Coronary Stenosis. Circ J. 2017 Jun 23;81(7):988-992. doi: 10.1253/circj.CJ-16-1261. Epub 2017 Mar 22.
Results Reference
background
PubMed Identifier
29980523
Citation
Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.
Results Reference
background
PubMed Identifier
27979031
Citation
Rimac G, Fearon WF, De Bruyne B, Ikeno F, Matsuo H, Piroth Z, Costerousse O, Bertrand OF. Clinical value of post-percutaneous coronary intervention fractional flow reserve value: A systematic review and meta-analysis. Am Heart J. 2017 Jan;183:1-9. doi: 10.1016/j.ahj.2016.10.005. Epub 2016 Oct 11.
Results Reference
background
PubMed Identifier
31199348
Citation
Azzalini L, Poletti E, Demir OM, Ancona MB, Mangieri A, Giannini F, Carlino M, Chieffo A, Montorfano M, Colombo A, Latib A. Impact of Post-Percutaneous Coronary Intervention Fractional Flow Reserve Measurement on Procedural Management and Clinical Outcomes: The REPEAT-FFR Study. J Invasive Cardiol. 2019 Aug;31(8):229-234. Epub 2019 Jun 15.
Results Reference
background
PubMed Identifier
29673507
Citation
Kikuta Y, Cook CM, Sharp ASP, Salinas P, Kawase Y, Shiono Y, Giavarini A, Nakayama M, De Rosa S, Sen S, Nijjer SS, Al-Lamee R, Petraco R, Malik IS, Mikhail GW, Kaprielian RR, Wijntjens GWM, Mori S, Hagikura A, Mates M, Mizuno A, Hellig F, Lee K, Janssens L, Horie K, Mohdnazri S, Herrera R, Krackhardt F, Yamawaki M, Davies J, Takebayashi H, Keeble T, Haruta S, Ribichini F, Indolfi C, Mayet J, Francis DP, Piek JJ, Di Mario C, Escaned J, Matsuo H, Davies JE. Pre-Angioplasty Instantaneous Wave-Free Ratio Pullback Predicts Hemodynamic Outcome In Humans With Coronary Artery Disease: Primary Results of the International Multicenter iFR GRADIENT Registry. JACC Cardiovasc Interv. 2018 Apr 23;11(8):757-767. doi: 10.1016/j.jcin.2018.03.005.
Results Reference
background

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Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty

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