Fracational Flow ReserveNCT04379947
Preoperative Use of Fractional Flow Reserve in CABG Use and Effectiveness of FFR-based CABG in Real-life Practice
An observational study of Fracational Flow Reserve and Coronary Artery Disease, run by University of Glasgow.
Trial summary
The use of fractional flow reserve (FFR) to guide coronary artery bypass graft (CABG) is controversial and not ubiquitously adopted across the units. There is no definitive evidence that the use of FFR improves early clinical outcomes after CABG, with the exception of a simplification of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracational Flow Reserve, Coronary Artery Disease, Coronary Artery Bypass Surgery
- What is being tested?
- Fractional Flow reserve
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Jan 2021
- 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
- Adult, Older adult
Study population: Patients will be retrospectively included in the study from 1st December 2010 to 31st December 2019. All surgical candidates with at least one intermediate lesion will be included. Patients that received a preoperative FFR evaluation before being referred for CABG will be part of the FFR-CABG group. The rest of the patients will be included in the Angio-CABG group. Inclusion will be on an "all-comers" basis including both elective and urgent (and urgent in-house) isolated CABG cases. However, patients undergoing emergency revascularization for iatrogenic complications or other conditions that would prevent a careful analysis of angiographic severity of the lesions will be excluded.
Who may be able to join
- all-comers" including both elective and urgent (and urgent in-house) isolated CABG cases
Who cannot join
- patients undergoing emergency revascularization for iatrogenic complications or other conditions that would prevent a careful analysis of angiographic severity of the lesions
About this study
Official title: A Real Life All-comers Retrospective Study on FFR-based CABG
The use of fractional flow reserve (FFR) to guide coronary artery bypass graft (CABG) is controversial and not ubiquitously adopted across the units. There is no definitive evidence that the use of FFR improves early clinical outcomes after CABG, with the exception of a simplification of the procedure. FFR use may help in defining the indication to the use arterial grafts, but there is no evidence that preoperative FFR lead to any benefits in terms of patency when venous grafts are used.
On these grounds a large multicentric all-comers observational study is planned. The aim is to achieve a real-life picture of the FFR practice in CABG across several European and non-European units. This study will inform on the effective use rate of FFR in the CABG practice and its clinical effectiveness when compared to standard angiography-based CABG.
Read the detailed description
Background The use of fractional flow reserve (FFR) to guide coronary artery bypass graft (CABG) is controversial. A large retrospective study on 627 patients by Toth et al. showed that FFR-guided surgery was associated with a lower number of graft anastomoses and a lower rate of on-pump surgery compared with angiography-guided coronary artery bypass graft surgery. This did not result in a higher event rate during up to 36 months of follow-up and was associated with a lower rate of angina. The six years follow-up of the same study showed that FFR-guided CABG was associated with a significant reduction in the rate of overall death or myocardial infarction at 6-year follow-up as compared with angiography-guided CABG.
However, the three randomized studies on FFR-based CABG have achieved contradictive results. The FARGO (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization) and GRAFFITI (GRAft patency after FFR-guided versus angiography-guided CABG) did not report a significant impact on hard outcomes at 1 year. Conversely, the IMPAG trial support the use of preoperative FFR in total arterial CABG. Authors found a significant association between the preoperative FFR measurement of the target vessel and the anastomotic functionality at 6 months, with a cut-off of 0.78. Authors concluded that integration of FFR measurement into the preoperative diagnostic workup could lead to improved anastomotic graft function.
The currently available randomized evidences might have been flawed by limitations including underpowering, entry selectivity bias, cross over among treatment, difference in the type of conduits used and presence of unexpected confounders related to surgeons' reluctance to base their surgical strategy on FFR. These drawbacks not only hamper the reliability of the results, but more importantly, reduce their translatability to the real-life clinical world.
Given the lack of definitive evidences and the difficulty of RCT to capture the real-life scenario of the clinical practice, we plan to perform a large multicentric all-comers study comparing the practice of FFR in CABG across several European and non-European units.
The main aim is to obtain information on
- Use rate of FFR in preoperative planning of surgical candidates
- Effective adherence to FFR guidance during elective surgery and identification of factors eventually limiting observance to FFR information
- Short and long-term outcomes of FFR-based CABG in comparison to standard angiography-based CABG
- Post hoc analysis in relation to type of conduit used, completeness of revascularization, surgeon experience, volume/outcome relationship.
- Being tested
- Fractional Flow reserve
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Flow reserveProcedure or surgery
Measurement of fractional flow reserve in the preoperative work-up for oronary artery bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| FFR-CABG | Patients with at least one intermediate stenosis that received a preoperative FFR evaluation before being referred for CABG Receives: Procedure: Fractional Flow reserve | |
| Angio-CABG | Patients with at least one intermediate stenosis that did not received a preoperative FFR evaluation before being referred for CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use rate of FFR in preoperative planning of surgical candidates
Frequency and rate of usage of fractional flow reserve measurement in the routine practice of Cath labs
Measured: 10 years
Effective adherence to FFR guidance during elective surgery and identification of factors eventually limiting observance to FFR information
To check if CABG operations are performed according to the guidance provided by FFR in terms of location and number of lesions to be bypassed
Measured: 10 years
Survival of FFR-based CABG in comparison to standard angiography-based CABG
Comparing mortality rate among the two groups
Measured: 10 years
Myocardial infarction rate in FFR-based CABG in comparison to standard angiography-based CABG
Comparing onset of myocardial infarction among the two groups
Measured: 10 years
Major cardiovascular events rate in FFR-based CABG in comparison to standard angiography-based CABG
Comparing occurrence of major cardiovascular events among the two groups
Measured: 10 years
Target vessel revascularization rate in FFR-based CABG in comparison to standard
Comparing perioperative mortality, myocardial infarction, major cardiovascular events, target vessel revascularization, long-term survival, long-term freedom from coronary intervention among the two groups
Measured: 10 years
Freedom from coronary intervention in FFR-based CABG compared to standard angiography-based CABG
Comparing long-term freedom from coronary intervention among the two groups
Measured: 10 years
Secondary outcomes (4)
Type of conduit used
Post-hoc analysis to investigated the use rate of arterial or venous conduit and the impact on clinical outcomes of the different conduits. This is crucial considering that the most recent randomized trial found a benefit of preoperative FFR when arterial conduits are used for CABG
Measured: 10 years
Completeness of revascularization
to investigate if the use of preoperative FFR is associated to incomplete revascularization (i.e. reduced number of bypassed lesion)
Measured: 10 years
Surgeon experience effect
Measuring relation between surgeon's experience (measured as number of CABG cases performed) on mortality and other outcomes. Studies have demonstrated a learning curve of at least 50 cases
Measured: 10 years
Volume/outcome relationship
Measuring relation between center's experience (measured as number of CABG cases/year) and outcomes.Centers performing high volumes of these procedure might produce better outcomes.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study startMay 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: research group's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fracational Flow ReserveStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiano Spadaccio, University of Glasgow
- Investigators
- Cristiano Spadaccio, MD, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379947
- Sponsor's protocol ID
- UG-003
- Status last verified
- Jul 2020
- First submitted
- 28 Apr 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: An anonymous standard data form has been created to retrieve relevant information. The database format along with instruction to insert data in a web-based password-protected database will be provided.
Publications
Sundermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T. Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery. Eur J Cardiothorac Surg. 2011 Jan;39(1):33-7. doi: 10.1016/j.ejcts.2010.04.013.
PubMed 20627611Coulson TG, Mullany DV, Reid CM, Bailey M, Pilcher D. Measuring the quality of perioperative care in cardiac surgery. Eur Heart J Qual Care Clin Outcomes. 2017 Jan 1;3(1):11-19. doi: 10.1093/ehjqcco/qcw027.
PubMed 28927188Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
PubMed 25173339Toth G, De Bruyne B, Casselman F, De Vroey F, Pyxaras S, Di Serafino L, Van Praet F, Van Mieghem C, Stockman B, Wijns W, Degrieck I, Barbato E. Fractional flow reserve-guided versus angiography-guided coronary artery bypass graft surgery. Circulation. 2013 Sep 24;128(13):1405-11. doi: 10.1161/CIRCULATIONAHA.113.002740. Epub 2013 Aug 28.
PubMed 23985788Fournier S, Toth GG, De Bruyne B, Johnson NP, Ciccarelli G, Xaplanteris P, Milkas A, Strisciuglio T, Bartunek J, Vanderheyden M, Wyffels E, Casselman F, Van Praet F, Stockman B, Degrieck I, Barbato E. Six-Year Follow-Up of Fractional Flow Reserve-Guided Versus Angiography-Guided Coronary Artery Bypass Graft Surgery. Circ Cardiovasc Interv. 2018 Jun;11(6):e006368. doi: 10.1161/CIRCINTERVENTIONS.117.006368.
PubMed 29848611Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Junker A, Mortensen PE, Jensen LO. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2018 Dec 4;72(22):2732-2743. doi: 10.1016/j.jacc.2018.09.043.
PubMed 30497559Toth GG, De Bruyne B, Kala P, Ribichini FL, Casselman F, Ramos R, Piroth Z, Fournier S, Piccoli A, Van Mieghem C, Penicka M, Mates M, Nemec P, Van Praet F, Stockman B, Degriek I, Barbato E. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention. 2019 Dec 6;15(11):e999-e1005. doi: 10.4244/EIJ-D-19-00463.
PubMed 31270037Glineur D, Grau JB, Etienne PY, Benedetto U, Fortier JH, Papadatos S, Laruelle C, Pieters D, El Khoury E, Blouard P, Timmermans P, Ruel M, Chong AY, So D, Chan V, Rubens F, Gaudino MF. Impact of preoperative fractional flow reserve on arterial bypass graft anastomotic function: the IMPAG trial. Eur Heart J. 2019 Aug 1;40(29):2421-2428. doi: 10.1093/eurheartj/ehz329.
PubMed 31155673Spadaccio C, Glineur D, Barbato E, Di Franco A, Oldroyd KG, Biondi-Zoccai G, Crea F, Fremes SE, Angiolillo DJ, Gaudino M. Fractional Flow Reserve-Based Coronary Artery Bypass Surgery: Current Evidence and Future Directions. JACC Cardiovasc Interv. 2020 May 11;13(9):1086-1096. doi: 10.1016/j.jcin.2019.12.017. Epub 2020 Mar 25.
PubMed 32222443
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real Life All-comers Retrospective Study on FFR-based CABG
- ClinicalTrials.gov ID
- NCT04379947
- Acronym / sponsor ID
- UG-003
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: research group's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 8 May 2020 (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.
The use of fractional flow reserve (FFR) to guide coronary artery bypass graft (CABG) is controversial and not ubiquitously adopted across the units. There is no definitive evidence that the use of FFR improves early clinical outcomes after CABG, with the exception of a simplification of the procedure. FFR use may help in defining the indication to the use arterial grafts, but there is no evidence that preoperative FFR lead to any benefits in terms of patency when venous grafts are used.
On these grounds a large multicentric all-comers observational study is planned. The aim is to achieve a real-life picture of the FFR practice in CABG across several European and non-European units. This study will inform on the effective use rate of FFR in the CABG practice and its clinical effectiveness when compared to standard angiography-based CABG.
Detailed description
Background The use of fractional flow reserve (FFR) to guide coronary artery bypass graft (CABG) is controversial. A large retrospective study on 627 patients by Toth et al. showed that FFR-guided surgery was associated with a lower number of graft anastomoses and a lower rate of on-pump surgery compared with angiography-guided coronary artery bypass graft surgery. This did not result in a higher event rate during up to 36 months of follow-up and was associated with a lower rate of angina. The six years follow-up of the same study showed that FFR-guided CABG was associated with a significant reduction in the rate of overall death or myocardial infarction at 6-year follow-up as compared with angiography-guided CABG.
However, the three randomized studies on FFR-based CABG have achieved contradictive results. The FARGO (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization) and GRAFFITI (GRAft patency after FFR-guided versus angiography-guided CABG) did not report a significant impact on hard outcomes at 1 year. Conversely, the IMPAG trial support the use of preoperative FFR in total arterial CABG. Authors found a significant association between the preoperative FFR measurement of the target vessel and the anastomotic functionality at 6 months, with a cut-off of 0.78. Authors concluded that integration of FFR measurement into the preoperative diagnostic workup could lead to improved anastomotic graft function.
The currently available randomized evidences might have been flawed by limitations including underpowering, entry selectivity bias, cross over among treatment, difference in the type of conduits used and presence of unexpected confounders related to surgeons' reluctance to base their surgical strategy on FFR. These drawbacks not only hamper the reliability of the results, but more importantly, reduce their translatability to the real-life clinical world.
Given the lack of definitive evidences and the difficulty of RCT to capture the real-life scenario of the clinical practice, we plan to perform a large multicentric all-comers study comparing the practice of FFR in CABG across several European and non-European units.
The main aim is to obtain information on
- Use rate of FFR in preoperative planning of surgical candidates
- Effective adherence to FFR guidance during elective surgery and identification of factors eventually limiting observance to FFR information
- Short and long-term outcomes of FFR-based CABG in comparison to standard angiography-based CABG
- Post hoc analysis in relation to type of conduit used, completeness of revascularization, surgeon experience, volume/outcome relationship.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR-CABG | – | Procedure: Fractional Flow reservePatients with at least one intermediate stenosis that received a preoperative FFR evaluation before being referred for CABG |
| Angio-CABG | – | –Patients with at least one intermediate stenosis that did not received a preoperative FFR evaluation before being referred for CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be retrospectively included in the study from 1st December 2010 to 31st December 2019. All surgical candidates with at least one intermediate lesion will be included. Patients that received a preoperative FFR evaluation before being referred for CABG will be part of the FFR-CABG group. The rest of the patients will be included in the Angio-CABG group. Inclusion will be on an "all-comers" basis including both elective and urgent (and urgent in-house) isolated CABG cases. However, patients undergoing emergency revascularization for iatrogenic complications or other conditions that would prevent a careful analysis of angiographic severity of the lesions will be excluded.
Key inclusion criteria (1 listed)
- all-comers" including both elective and urgent (and urgent in-house) isolated CABG cases
Key exclusion criteria (1 listed)
- patients undergoing emergency revascularization for iatrogenic complications or other conditions that would prevent a careful analysis of angiographic severity of the lesions
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 |
|---|---|---|
| Fractional Flow reserveMeasurement of fractional flow reserve in the preoperative work-up for oronary artery bypass surgery | Procedure or surgery | FFR-CABG |
Primary outcome
Use rate of FFR in preoperative planning of surgical candidates
Time frame: 10 years
Frequency and rate of usage of fractional flow reserve measurement in the routine practice of Cath labs
Effective adherence to FFR guidance during elective surgery and identification of factors eventually limiting observance to FFR information
Time frame: 10 years
To check if CABG operations are performed according to the guidance provided by FFR in terms of location and number of lesions to be bypassed
Survival of FFR-based CABG in comparison to standard angiography-based CABG
Time frame: 10 years
Comparing mortality rate among the two groups
Myocardial infarction rate in FFR-based CABG in comparison to standard angiography-based CABG
Time frame: 10 years
Comparing onset of myocardial infarction among the two groups
Major cardiovascular events rate in FFR-based CABG in comparison to standard angiography-based CABG
Time frame: 10 years
Comparing occurrence of major cardiovascular events among the two groups
Target vessel revascularization rate in FFR-based CABG in comparison to standard
Time frame: 10 years
Comparing perioperative mortality, myocardial infarction, major cardiovascular events, target vessel revascularization, long-term survival, long-term freedom from coronary intervention among the two groups
Freedom from coronary intervention in FFR-based CABG compared to standard angiography-based CABG
Time frame: 10 years
Comparing long-term freedom from coronary intervention among the two groups
4 secondary outcomes
Type of conduit used
Time frame: 10 years
Completeness of revascularization
Time frame: 10 years
Surgeon experience effect
Time frame: 10 years
Volume/outcome relationship
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Background: PubMed 20627611Sundermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T. Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery. Eur J Cardiothorac Surg. 2011 Jan;39(1):33-7. doi: 10.1016/j.ejcts.2010.04.013.
- Background: PubMed 28927188Coulson TG, Mullany DV, Reid CM, Bailey M, Pilcher D. Measuring the quality of perioperative care in cardiac surgery. Eur Heart J Qual Care Clin Outcomes. 2017 Jan 1;3(1):11-19. doi: 10.1093/ehjqcco/qcw027.
- Background: PubMed 25173339Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
- Results publication: PubMed 23985788Toth G, De Bruyne B, Casselman F, De Vroey F, Pyxaras S, Di Serafino L, Van Praet F, Van Mieghem C, Stockman B, Wijns W, Degrieck I, Barbato E. Fractional flow reserve-guided versus angiography-guided coronary artery bypass graft surgery. Circulation. 2013 Sep 24;128(13):1405-11. doi: 10.1161/CIRCULATIONAHA.113.002740. Epub 2013 Aug 28.
- Results publication: PubMed 29848611Fournier S, Toth GG, De Bruyne B, Johnson NP, Ciccarelli G, Xaplanteris P, Milkas A, Strisciuglio T, Bartunek J, Vanderheyden M, Wyffels E, Casselman F, Van Praet F, Stockman B, Degrieck I, Barbato E. Six-Year Follow-Up of Fractional Flow Reserve-Guided Versus Angiography-Guided Coronary Artery Bypass Graft Surgery. Circ Cardiovasc Interv. 2018 Jun;11(6):e006368. doi: 10.1161/CIRCINTERVENTIONS.117.006368.
- Results publication: PubMed 30497559Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Junker A, Mortensen PE, Jensen LO. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2018 Dec 4;72(22):2732-2743. doi: 10.1016/j.jacc.2018.09.043.
- Results publication: PubMed 31270037Toth GG, De Bruyne B, Kala P, Ribichini FL, Casselman F, Ramos R, Piroth Z, Fournier S, Piccoli A, Van Mieghem C, Penicka M, Mates M, Nemec P, Van Praet F, Stockman B, Degriek I, Barbato E. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention. 2019 Dec 6;15(11):e999-e1005. doi: 10.4244/EIJ-D-19-00463.
- Results publication: PubMed 31155673Glineur D, Grau JB, Etienne PY, Benedetto U, Fortier JH, Papadatos S, Laruelle C, Pieters D, El Khoury E, Blouard P, Timmermans P, Ruel M, Chong AY, So D, Chan V, Rubens F, Gaudino MF. Impact of preoperative fractional flow reserve on arterial bypass graft anastomotic function: the IMPAG trial. Eur Heart J. 2019 Aug 1;40(29):2421-2428. doi: 10.1093/eurheartj/ehz329.
- Results publication: PubMed 32222443Spadaccio C, Glineur D, Barbato E, Di Franco A, Oldroyd KG, Biondi-Zoccai G, Crea F, Fremes SE, Angiolillo DJ, Gaudino M. Fractional Flow Reserve-Based Coronary Artery Bypass Surgery: Current Evidence and Future Directions. JACC Cardiovasc Interv. 2020 May 11;13(9):1086-1096. doi: 10.1016/j.jcin.2019.12.017. Epub 2020 Mar 25.
- Individual participant dataSharing planned: No. An anonymous standard data form has been created to retrieve relevant information. The database format along with instruction to insert data in a web-based password-protected database will be provided.
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.
Cristiano Spadaccio, MD, PhD principal investigator
University of Glasgow
Questions about this trial
What is this clinical trial studying?
An observational study of Fracational Flow Reserve and Coronary Artery Disease, run by University of Glasgow.
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 1 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: withdrawn, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Use rate of FFR in preoperative planning of surgical candidates (time frame: 10 years). The study lists 7 primary outcomes in all. 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 NCT04379947, which also lists 9 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 13 Jul 2020.