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Coronary OcclusionQIMERA-INCT04200469

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

A study testing Quantitative Flow Ratio (QFR) measurement in people with Coronary Occlusion, run by Hospital Clínico Universitario de Valladolid at 5 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Occlusion
What is being tested?
Quantitative Flow Ratio (QFR) measurement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
5 sitesSpain
Study dates
1 Jan 2020to 31 Jan 2022
Phase
Interventional
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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

Carlos Baladron, PhD contact

+34983420000

icicor@icicor.es

5 sites in 1 country

Spain5 sites, 5 recruiting

  • Hospital de Lugo

    Lugo

    Raymundo Ocaranza-Sanchez, PhD, MD

    Recruiting

  • Hospital Clínico San Carlos

    Madrid

    Javier Escaned, PhD, MD

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia

    Eduardo Pinar, PhD

    Ramon López-Palop, PhD, MD

    Recruiting

  • Complejo Hospitalario Universitario, Santiago de Compostela

    Santiago de Compostela, La Coruña

    José R Rumoroso, MD

    Mario Sadaba

    Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

    Carlos Baladron, Dr., 983420000

    Alfredo Redondo-Diéguez, MD

    Recruiting

Other trials in Spain

About this study

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.

Being tested
Quantitative Flow Ratio (QFR) measurement
Keywords
Quantitative Flow Ratio, QFR, Percutaneous Coronary Intervention
Medical subject headings
Coronary Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quantitative Flow Ratio (QFR) measurementDiagnostic test

    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.

Study groups in NCT04200469
Study groupRoleWhat they receive
QFR InterventionExperimentalPatients 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.
Receives: Diagnostic Test: Quantitative Flow Ratio (QFR) measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 hour

Secondary outcomes (8)

  1. Sensitivity

    Measured: 1 hour

  2. Specificity

    Measured: 1 hour

  3. Summary of the receiver-operator characteristics curve (sROC)

    Measured: 1 hour

  4. Negative predictive value

    Measured: 1 hour

  5. Positive predictive value

    Measured: 1 hour

  6. Positive likelihood ratio

    Measured: 1 hour

  7. Negative likelihood ratio

    Measured: 1 hour

  8. Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200469
Sponsor's protocol ID
CASVE-PI-19-1515
Acronym
QIMERA-I
Status last verified
Sep 2021
First submitted
13 Dec 2019
Last updated
24 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28356440

  • 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.

    PubMed 9525557

  • 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.

    PubMed 11413082

  • 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.

    PubMed 17531660

  • 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.

    PubMed 26733607

  • 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.

    PubMed 28317458

  • 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.

    PubMed 28317438

  • 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.

    PubMed 30165437

  • 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.

    PubMed 29555835

  • 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.

    PubMed 28642995

  • 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.

    PubMed 28331135

  • 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.

    PubMed 29980523

  • 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.

    PubMed 27979031

  • 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. doi: 10.25270/jic/19.3108.229. Epub 2019 Jun 15.

    PubMed 31199348

  • 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.

    PubMed 29673507

Questions about this trial

What is this clinical trial studying?

A study testing Quantitative Flow Ratio (QFR) measurement in people with Coronary Occlusion, run by Hospital Clínico Universitario de Valladolid at 5 sites in Spain.

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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carlos Baladron, PhD (+34983420000, icicor@icicor.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT04200469, which also lists 15 linked publications.

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 24 Sep 2021.

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