Coronary DiseasePOST-PCI FLOWNCT04684043
Prognostic Implications of Physiologic Investigation After Revascularization With Stent
An observational study of Coronary Disease, run by Bon-Kwon Koo at 1 site in South Korea.
Trial summary
Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI) and revascularization compared to medical therapy. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 5,100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 May 2020to 28 Feb 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 20 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients who were diagnosed as obstructive coronary artery disease and treated by DES and measured post PCI FFR after PCI.
Articles were included when they met the following prespecified criteria: (1) included the patients who underwent PCI with drug-eluting stent (DES); (2) post-PCI FFR was measured after DES implantation; (3) pre-PCI FFR measurement was not mandatory for article inclusion; (4) patients were followed up at least 6 months; (5) clinical outcomes, including all-cause death, cardiac death, target vessel myocardial infarction (TVMI) or target vessel revascularization (TVR), were clearly reported; (6) randomized controlled trials or non-randomized prospective or retrospective registries were included. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the studies' inclusion. The third investigator supervised the searching process and adjudicated all the disagreements.
- Patients with life expectancy < 2 years.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Select, 03080
Bon-Kwon Koo, MD, PhD, +82-1033561869, bkkoo@snu.ac.kr
Seokhun Yang, MD, +82-1025953470, newturnz7@gmail.com
About this study
Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI) and revascularization compared to medical therapy. However, the risk of future clinical events remains high, and about 10% of patients experienced further cardiovascular events after PCI. Several factors are associated with these poor outcomes. Well known patient-related risk factors are diabetes mellitus, chronic kidney disease, left ventricular dysfunction, previous MI, and presentation with the acute coronary syndrome. Procedure-related factors, such as stent underexpension, malapposition, edge dissection, the number of the used stent, and total stent length, are also related to poor prognosis after PCI. Recent studies reported that fractional flow reserve (FFR) after coronary stenting, or post PCI FFR, was associated with future clinical outcomes after PCI, and low post PCI FFR value was associated with procedural factors. However, optimal cut-off values of post-PCI FFR ranged widely, from 0.86 to 0.96, and some study reported the limited prognostic value of post-PCI FFR. This might result from differences in study populations, the definition of outcomes, type of stent used, and distribution of included vessels among previous studies.
To establish the clinical relevance of post-PCI FFR and to evaluate the useful cut-off value of post-PCI FFR in daily practice, investigators planned to incorporate all previous evidence of post-PCI FFR by collaboration with international researchers.
Read the detailed description
This study population was incorporated from studies which were already published. Investigators will incorporate all known registries to the POST-PCI FLOW registry by requesting data from principal investigator of each registry.
Investigators will perform systemic review of the previous published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. Searching key words included 'post', 'after', 'PCI', 'Percutaneous coronary intervention', 'coronary stenting', 'stenting', 'stent', 'stent implantation', 'FFR', and 'fractional flow reserve'.
- Conditions
- Coronary Disease
- Being tested
- Percutaneous coronary intervention
- Keywords
- fractional flow reserve, percutaneous coronary intervention, drug-eluting stent, coronary atherosclerosis
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
PCI was performed using drug-eluting stents
| Study group | Role | What they receive |
|---|---|---|
| Post PCI state | The study population of this study underwent percutaneous coronary intervention(PCI) with drug-eluting stent (DES) and measured fractional flow reserve after PCI. Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure
A composite of cardiac death, target vessel myocardial infarction and target vessel revascularization
Measured: 2 years
Secondary outcomes (3)
Cardiac death or myocardial infarction
a composite of cardiac death and target vessel myocardial infarction
Measured: 2 years
Target vessel myocardial infarction
Measured: 2 years
Target vessel revascularization
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start16 May 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary 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
- Retrospective
- Enrolment
- 5,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bon-Kwon Koo
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University Ilsan Paik Hospital, Goyang, South Korea, Nanjing First Hospital, Nanjing Medical University, Tsuchiura Kyodo General Hospital, McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA, Nagoya City University Graduate School of Medical Science, Nagoya, Japan, Rutgers Robert Wood Johnson Medical School, Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium, San Raffaele Scientific Institute, Milan, Italy, Ajou University School of Medicine, University of Cincinnati, Kyoto Second Red Cross Hospital, Kyoto, Japan, Samsung Medical Center, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan
- Responsible party
- Sponsor-investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Study chair, Seoul National University Hospital, Seoul, South KoreaJoon Hyung MD, PhD, MD, PhD, Principal investigator, Inje University Ilsan Paik Hospital, Goyang, South KoreaShao-Liang Chen, MD, Principal investigator, Nanjing First Hospital, Nanjing Medical UniversityTsunekazu Kakuta, MD, PhD, Principal investigator, Tsuchiura Kyodo General HospitalNils P. Johnson, MD, MS, Principal investigator, McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USATsuyoshi Ito, MD, Principal investigator, Nagoya City University Graduate School of Medical Science, Nagoya, JapanAbdul Hakeem, MD, Principal investigator, Rutgers Robert Wood Johnson Medical SchoolBernard De Bruyne, MD, PhD, Principal investigator, Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684043
- Sponsor's protocol ID
- H-2009-042-1155
- Acronym
- POST-PCI FLOW
- Status last verified
- Feb 2021
- First submitted
- 22 Dec 2020
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 30165437Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Juni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2.
PubMed 29097450Hwang D, Lee JM, Lee HJ, Kim SH, Nam CW, Hahn JY, Shin ES, Matsuo A, Tanaka N, Matsuo H, Lee SY, Doh JH, Koo BK. Influence of target vessel on prognostic relevance of fractional flow reserve after coronary stenting. EuroIntervention. 2019 Aug 29;15(5):457-464. doi: 10.4244/EIJ-D-18-00913.
PubMed 30561367Li SJ, Ge Z, Kan J, Zhang JJ, Ye F, Kwan TW, Santoso T, Yang S, Sheiban I, Qian XS, Tian NL, Rab TS, Tao L, Chen SL. Cutoff Value and Long-Term Prediction of Clinical Events by FFR Measured Immediately After Implantation of a Drug-Eluting Stent in Patients With Coronary Artery Disease: 1- to 3-Year Results From the DKCRUSH VII Registry Study. JACC Cardiovasc Interv. 2017 May 22;10(10):986-995. doi: 10.1016/j.jcin.2017.02.012. Epub 2017 Apr 26.
PubMed 28456699Rimac 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 27979031van Zandvoort LJC, Masdjedi K, Witberg K, Ligthart J, Tovar Forero MN, Diletti R, Lemmert ME, Wilschut J, de Jaegere PPT, Boersma E, Zijlstra F, Van Mieghem NM, Daemen J. Explanation of Postprocedural Fractional Flow Reserve Below 0.85. Circ Cardiovasc Interv. 2019 Feb;12(2):e007030. doi: 10.1161/CIRCINTERVENTIONS.118.007030.
PubMed 30732469Choi KH, Kwon W, Shin D, Lee SH, Hwang D, Zhang J, Nam CW, Shin ES, Doh JH, Chen SL, Kakuta T, Toth GG, Piroth Z, Hakeem A, Uretsky BF, Hokama Y, Tanaka N, Lim HS, Ito T, Matsuo A, Azzalini L, Leesar MA, Daemen J, Collison D, Collet C, De Bruyne B, Koo BK, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Differential Impact of Fractional Flow Reserve Measured After Coronary Stent Implantation by Left Ventricular Dysfunction. JACC Asia. 2023 Dec 12;4(3):229-240. doi: 10.1016/j.jacasi.2023.10.009. eCollection 2024 Mar.
PubMed 38463680Yang S, Hwang D, Zhang J, Park J, Yun JP, Lee JM, Nam CW, Shin ES, Doh JH, Chen SL, Kakuta T, Toth GG, Piroth Z, Johnson NP, Hakeem A, Uretsky BF, Hokama Y, Tanaka N, Lim HS, Ito T, Matsuo A, Azzalini L, Leesar MA, Neleman T, van Mieghem NM, Diletti R, Daemen J, Collison D, Collet C, De Bruyne B, Koo BK. Clinical and Vessel Characteristics Associated With Hard Outcomes After PCI and Their Combined Prognostic Implications. J Am Heart Assoc. 2023 Sep 5;12(17):e030572. doi: 10.1161/JAHA.123.030572. Epub 2023 Aug 29.
PubMed 37642032
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Implications of Physiologic Investigation After Revascularization With Stent
- ClinicalTrials.gov ID
- NCT04684043
- Acronym / sponsor ID
- POST-PCI FLOW / H-2009-042-1155
- Conditions
- Coronary Disease
- Keywords
- fractional flow reserve, percutaneous coronary intervention, drug-eluting stent, coronary atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,100 participants (estimated)
- Lead sponsor
- Bon-Kwon KooUniversity, hospital or other
- Collaborators
- Inje University Ilsan Paik Hospital, Goyang, South Korea, Nanjing First Hospital, Nanjing Medical University, Tsuchiura Kyodo General Hospital, McGovern Medical School at UTHealth and Memorial Hermann Hospital, TX, USA, Nagoya City University Graduate School of Medical Science, Nagoya, Japan, Rutgers Robert Wood Johnson Medical School, Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium, San Raffaele Scientific Institute, Milan, Italy, Ajou University School of Medicine, University of Cincinnati, Kyoto Second Red Cross Hospital, Kyoto, Japan, Samsung Medical Center, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan
- Study start
- 16 May 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 24 Dec 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.
Percutaneous coronary intervention (PCI) is a standard treatment strategy for coronary artery disease (CAD). With the presence of myocardial ischemia, PCI reduces the risks of death, myocardial infarction (MI) and revascularization compared to medical therapy. However, the risk of future clinical events remains high, and about 10% of patients experienced further cardiovascular events after PCI. Several factors are associated with these poor outcomes. Well known patient-related risk factors are diabetes mellitus, chronic kidney disease, left ventricular dysfunction, previous MI, and presentation with the acute coronary syndrome. Procedure-related factors, such as stent underexpension, malapposition, edge dissection, the number of the used stent, and total stent length, are also related to poor prognosis after PCI. Recent studies reported that fractional flow reserve (FFR) after coronary stenting, or post PCI FFR, was associated with future clinical outcomes after PCI, and low post PCI FFR value was associated with procedural factors. However, optimal cut-off values of post-PCI FFR ranged widely, from 0.86 to 0.96, and some study reported the limited prognostic value of post-PCI FFR. This might result from differences in study populations, the definition of outcomes, type of stent used, and distribution of included vessels among previous studies.
To establish the clinical relevance of post-PCI FFR and to evaluate the useful cut-off value of post-PCI FFR in daily practice, investigators planned to incorporate all previous evidence of post-PCI FFR by collaboration with international researchers.
Detailed description
This study population was incorporated from studies which were already published. Investigators will incorporate all known registries to the POST-PCI FLOW registry by requesting data from principal investigator of each registry.
Investigators will perform systemic review of the previous published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. Searching key words included 'post', 'after', 'PCI', 'Percutaneous coronary intervention', 'coronary stenting', 'stenting', 'stent', 'stent implantation', 'FFR', and 'fractional flow reserve'.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post PCI state | – | Device: Percutaneous coronary interventionThe study population of this study underwent percutaneous coronary intervention(PCI) with drug-eluting stent (DES) and measured fractional flow reserve after PCI. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed as obstructive coronary artery disease and treated by DES and measured post PCI FFR after PCI.
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 |
|---|---|---|
| Percutaneous coronary interventionPCI was performed using drug-eluting stents | Device | Post PCI state |
Primary outcome
Target vessel failure
Time frame: 2 years
A composite of cardiac death, target vessel myocardial infarction and target vessel revascularization
3 secondary outcomes
Cardiac death or myocardial infarction
Time frame: 2 years
Target vessel myocardial infarction
Time frame: 2 years
Target vessel revascularization
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Background: PubMed 30165437Neumann 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.
- Background: PubMed 29097450Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Juni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2.
- Background: PubMed 30561367Hwang D, Lee JM, Lee HJ, Kim SH, Nam CW, Hahn JY, Shin ES, Matsuo A, Tanaka N, Matsuo H, Lee SY, Doh JH, Koo BK. Influence of target vessel on prognostic relevance of fractional flow reserve after coronary stenting. EuroIntervention. 2019 Aug 29;15(5):457-464. doi: 10.4244/EIJ-D-18-00913.
- Background: PubMed 28456699Li SJ, Ge Z, Kan J, Zhang JJ, Ye F, Kwan TW, Santoso T, Yang S, Sheiban I, Qian XS, Tian NL, Rab TS, Tao L, Chen SL. Cutoff Value and Long-Term Prediction of Clinical Events by FFR Measured Immediately After Implantation of a Drug-Eluting Stent in Patients With Coronary Artery Disease: 1- to 3-Year Results From the DKCRUSH VII Registry Study. JACC Cardiovasc Interv. 2017 May 22;10(10):986-995. doi: 10.1016/j.jcin.2017.02.012. Epub 2017 Apr 26.
- Background: PubMed 27979031Rimac 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.
- Background: PubMed 30732469van Zandvoort LJC, Masdjedi K, Witberg K, Ligthart J, Tovar Forero MN, Diletti R, Lemmert ME, Wilschut J, de Jaegere PPT, Boersma E, Zijlstra F, Van Mieghem NM, Daemen J. Explanation of Postprocedural Fractional Flow Reserve Below 0.85. Circ Cardiovasc Interv. 2019 Feb;12(2):e007030. doi: 10.1161/CIRCINTERVENTIONS.118.007030.
- Derived from this study: PubMed 38463680Choi KH, Kwon W, Shin D, Lee SH, Hwang D, Zhang J, Nam CW, Shin ES, Doh JH, Chen SL, Kakuta T, Toth GG, Piroth Z, Hakeem A, Uretsky BF, Hokama Y, Tanaka N, Lim HS, Ito T, Matsuo A, Azzalini L, Leesar MA, Daemen J, Collison D, Collet C, De Bruyne B, Koo BK, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Differential Impact of Fractional Flow Reserve Measured After Coronary Stent Implantation by Left Ventricular Dysfunction. JACC Asia. 2023 Dec 12;4(3):229-240. doi: 10.1016/j.jacasi.2023.10.009. eCollection 2024 Mar.
- Derived from this study: PubMed 37642032Yang S, Hwang D, Zhang J, Park J, Yun JP, Lee JM, Nam CW, Shin ES, Doh JH, Chen SL, Kakuta T, Toth GG, Piroth Z, Johnson NP, Hakeem A, Uretsky BF, Hokama Y, Tanaka N, Lim HS, Ito T, Matsuo A, Azzalini L, Leesar MA, Neleman T, van Mieghem NM, Diletti R, Daemen J, Collison D, Collet C, De Bruyne B, Koo BK. Clinical and Vessel Characteristics Associated With Hard Outcomes After PCI and Their Combined Prognostic Implications. J Am Heart Assoc. 2023 Sep 5;12(17):e030572. doi: 10.1161/JAHA.123.030572. Epub 2023 Aug 29.
- Individual participant dataSharing planned: Undecided
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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.
Bon-Kwon Koo, MD, PhD study chair
Seoul National University Hospital, Seoul, South Korea
Joon Hyung MD, PhD, MD, PhD principal investigator
Inje University Ilsan Paik Hospital, Goyang, South Korea
Shao-Liang Chen, MD principal investigator
Nanjing First Hospital, Nanjing Medical University
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 Disease, run by Bon-Kwon Koo at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Feb 2021. 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 South Korea. 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 Bon-Kwon Koo, MD, PhD (82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (time frame: 2 years). 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 NCT04684043, which also lists 8 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 26 Feb 2021.