Coronary OcclusionANGELINENCT04604197
ANGiographic Evaluation of Left Main Coronary Artery INtErvention
A study testing Angiography and Clinical Follow up and Clinical Follow up in people with Coronary Occlusion and Left Main Coronary Artery Disease, run by Fundación EPIC at 30 sites in Spain.
Trial summary
To assess if an angiographic follow-up at 6 months after Percutaneous Coronary Intervention in Left Main Coronary Artery Disease decrease the composite objective of death, myocardial infarction, and stroke at 36 months. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Occlusion, Left Main Coronary Artery Disease, Coronary Artery Stenosis
- What is being tested?
- Angiography and Clinical Follow up and Clinical Follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 30 sitesSpain
- Study dates
- 16 Apr 2021to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18- 85 years at the date of the PCI.
- With PCI for presenting de novo lesions in the Left Main Artery by implanting a cobalt-chrome stent with everolimus-eluting fluoropolymer.
- Informed consent signed.
Who cannot join
- Refusal to participate in the study.
- Patients with left main disease who have been admitted with STEMI and have undergone primary angioplasty in a culprit lesion different than the left main. The left main lesion has been treated as a stage procedure and discharged with left ventricular ejection fraction < 35 %.
- Previous coronary surgery.
- Creatinine clearance <40 ml / min.
- Contraindication for double antiaggregation after PCI.
- Patients life expectancy <36 months.
- Included in other studies or clinical trials.
- Pregnant or lactating women.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Spain30 sites
Hospital Universitario de A Coruña
A Coruña, 15006
Hospital General Universitario de Albacete
Albacete, 02006
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario San Juan de Alicante
Alicante
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, 08916
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital Del Mar
Barcelona, 08003
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Universitari Bellvitge
Barcelona, 08907
Hospital Universitario de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, 20014
Hospital Galdakao-Usansolo
Galdakao, Vizcaya, 48960
Hospital Universitario de Cabueñes
Gijón, 33394
Hospital Universitario Virgen de Las Nieves
Granada, 18014
Hospital General Juan Ramón Jiménez
Huelva, 21005
Hospital Universitario de León
León, 24071
Hospital Universitario Lucus Agusti
Lugo, 27003
Hospital Universitario La Princesa
Madrid, 28006
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Regional de Malaga
Málaga, Malaga, 29010
Hospital Universitario Virgen Arrixaca
Murcia, 30120
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
To assess if an angiographic follow-up at 6 months after Percutaneous Coronary Intervention in Left Main Coronary Artery Disease decrease the composite objective of death, myocardial infarction, and stroke at 36 months.
Read the detailed description
Percutaneous coronary intervention (PCI) with drug-eluting stents in left main (LM) disease has demonstrated similar results than surgical revascularization in patients with SYNTAX score < 33, being the main drawback of PCI a higher rate of new revascularization. A small study found a reduction in the composite end-point of cardiac death, myocardial infarction and urgent revascularization with a routine angiographic follow-up. The investigators have designed a prospective, randomized, controlled, two-arm multicenter study in patients aged 18-85 with LM disease and SYNTAX score <33 and in cases ≥ 33 based on the Heart Team decision to assess the benefit of a routine angiographic follow-up 6 months after LM stenting. After the index procedure and before hospital discharge the patient will be randomized to routine invasive angiographic follow-up at 6 months plus clinical follow-up at 6 months, 1, 2 and 3 years vs. the control arm, which would be followed clinically at 6 months, 1, 2 and 3 years. Based on our calculations, an adequately powered trial would require 1009 patients per arm but due to the uncertainty of the results and the current economical restrictions we have designed a pilot study in 400 patients to find out the convenience of an adequately powered trial. All the lesions should be treated with an everolimus eluting stent with permanent fluoropolymer. It will be desirable to achieve complete revascularization and it will be highly recommended to perform the procedures guided with an intravascular image technique (OCT or IVUS (IntraVascular UltraSound) according to operator´s criteria). The main outcome will be death, myocardial infarction and cerebrovascular accident at 3 years. The initial percutaneous technique and the decision about the convenience and way of revascularization in case of restenosis in the follow-up will be left at the operator´s discretion, according in the most adequate way to the current guidelines. Nonetheless, the investigators are strongly encouraged to rely on intravascular techniques, based on either imaging or physiology. In those cases with in-stent hyperplasia with doubts about possible restenosis, FFR and RFR (Resting full-cycle ratio) will be performed, with low threshold to achieve a high rate of ruling out the restenosis.
- Conditions
- Coronary Occlusion, Left Main Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Being tested
- Angiography and Clinical Follow up, Clinical Follow up
- Keywords
- Angiography
- Medical subject headings
- Coronary Occlusion, Coronary Artery Disease, Coronary Stenosis, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography and Clinical Follow upOther
Angiography and Clinical Follow up
Clinical Follow upOther
Clinical Follow up
| Study group | Role | What they receive |
|---|---|---|
| Angiography and Clinical Follow up | Experimental | After PCI. The patient is randomized to an angiographic follow-up at 6 months and a Clinical Follow to 36 months Receives: Other: Angiography and Clinical Follow up |
| Clinical Follow up | Active comparator | After PCI. The patient is randomized to a Clinical Follow to 36 months Receives: Other: Clinical Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint: defined as : death, myocardial infarction, and stroke.
Composite endpoint: defined as : death, myocardial infarction, and stroke.
Measured: 36 months
Secondary outcomes (8)
All Death
Occurrence of Death
Measured: 36 months
Cardiac Death
Occurrence of Cardiac Death
Measured: 36 months
Myocardial Infarction
Occurrence of Myocardial Infarction
Measured: 36 months
Stroke
Occurrence of Stroke
Measured: 36 months
Stent thrombosis (ARC definite/probable)
Occurrence of thrombosis (ARC definite/probable)
Measured: 36 months
Major bleeding event (BARC type 2-5)
Occurrence of Major bleeding event (BARC type 2-5)
Measured: 36 months
Target Vessel revascularization.
Occurrence of Target Vessel revascularization.
Measured: 36 months
Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention)
Occurrence of New revascularization by CABG or PCI
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start16 Apr 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary OcclusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604197
- Sponsor's protocol ID
- EPIC23-ANGELINE
- Acronym
- ANGELINE
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cavalcante R, Sotomi Y, Lee CW, Ahn JM, Farooq V, Tateishi H, Tenekecioglu E, Zeng Y, Suwannasom P, Collet C, Albuquerque FN, Onuma Y, Park SJ, Serruys PW. Outcomes After Percutaneous Coronary Intervention or Bypass Surgery in Patients With Unprotected Left Main Disease. J Am Coll Cardiol. 2016 Sep 6;68(10):999-1009. doi: 10.1016/j.jacc.2016.06.024.
PubMed 27585503Puri R, de la Torre Hernandez JM, Auffret V. Routine Surveillance Coronary Angiography Post-PCI: Should We ReACT and Change Our Routine? JACC Cardiovasc Interv. 2017 Jan 23;10(2):118-120. doi: 10.1016/j.jcin.2016.11.020. Epub 2016 Dec 28. No abstract available.
PubMed 28040444Aurigemma C, Burzotta F, Porto I, Niccoli G, Leone AM, Crea F, Trani C. Clinical impact of routine angiographic follow-up after percutaneous coronary interventions on unprotected left main. Cardiol J. 2018;25(5):582-588. doi: 10.5603/CJ.a2018.0092. Epub 2018 Aug 29.
PubMed 30155864Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31.
PubMed 27797291Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31.
PubMed 27810312Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM 3rd, Lembo NJ, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman PE, Bochenek A, Schampaert E, Page P, Modolo R, Gregson J, Simonton CA, Mehran R, Kosmidou I, Genereux P, Crowley A, Dressler O, Serruys PW; EXCEL Trial Investigators. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med. 2019 Nov 7;381(19):1820-1830. doi: 10.1056/NEJMoa1909406. Epub 2019 Sep 28.
PubMed 31562798
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANGiographic Evaluation of Left Main Coronary Artery INtErvention
- ClinicalTrials.gov ID
- NCT04604197
- Acronym / sponsor ID
- ANGELINE / EPIC23-ANGELINE
- Conditions
- Coronary Occlusion, Left Main Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Keywords
- Angiography
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Oct 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.
To assess if an angiographic follow-up at 6 months after Percutaneous Coronary Intervention in Left Main Coronary Artery Disease decrease the composite objective of death, myocardial infarction, and stroke at 36 months.
Detailed description
Percutaneous coronary intervention (PCI) with drug-eluting stents in left main (LM) disease has demonstrated similar results than surgical revascularization in patients with SYNTAX score < 33, being the main drawback of PCI a higher rate of new revascularization. A small study found a reduction in the composite end-point of cardiac death, myocardial infarction and urgent revascularization with a routine angiographic follow-up. The investigators have designed a prospective, randomized, controlled, two-arm multicenter study in patients aged 18-85 with LM disease and SYNTAX score <33 and in cases ≥ 33 based on the Heart Team decision to assess the benefit of a routine angiographic follow-up 6 months after LM stenting. After the index procedure and before hospital discharge the patient will be randomized to routine invasive angiographic follow-up at 6 months plus clinical follow-up at 6 months, 1, 2 and 3 years vs. the control arm, which would be followed clinically at 6 months, 1, 2 and 3 years. Based on our calculations, an adequately powered trial would require 1009 patients per arm but due to the uncertainty of the results and the current economical restrictions we have designed a pilot study in 400 patients to find out the convenience of an adequately powered trial. All the lesions should be treated with an everolimus eluting stent with permanent fluoropolymer. It will be desirable to achieve complete revascularization and it will be highly recommended to perform the procedures guided with an intravascular image technique (OCT or IVUS (IntraVascular UltraSound) according to operator´s criteria). The main outcome will be death, myocardial infarction and cerebrovascular accident at 3 years. The initial percutaneous technique and the decision about the convenience and way of revascularization in case of restenosis in the follow-up will be left at the operator´s discretion, according in the most adequate way to the current guidelines. Nonetheless, the investigators are strongly encouraged to rely on intravascular techniques, based on either imaging or physiology. In those cases with in-stent hyperplasia with doubts about possible restenosis, FFR and RFR (Resting full-cycle ratio) will be performed, with low threshold to achieve a high rate of ruling out the restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiography and Clinical Follow up | Experimental | Other: Angiography and Clinical Follow upAfter PCI. The patient is randomized to an angiographic follow-up at 6 months and a Clinical Follow to 36 months |
| Clinical Follow up | Active comparator | Other: Clinical Follow upAfter PCI. The patient is randomized to a Clinical Follow to 36 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18- 85 years at the date of the PCI.
- With PCI for presenting de novo lesions in the Left Main Artery by implanting a cobalt-chrome stent with everolimus-eluting fluoropolymer.
- Informed consent signed.
Key exclusion criteria (8 listed)
- Refusal to participate in the study.
- Patients with left main disease who have been admitted with STEMI and have undergone primary angioplasty in a culprit lesion different than the left main. The left main lesion has been treated as a stage procedure and discharged with left ventricular ejection fraction < 35 %.
- Previous coronary surgery.
- Creatinine clearance <40 ml / min.
- Contraindication for double antiaggregation 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 |
|---|---|---|
| Angiography and Clinical Follow upAngiography and Clinical Follow up | Other | Angiography and Clinical Follow up |
| Clinical Follow upClinical Follow up | Other | Clinical Follow up |
Primary outcome
Composite endpoint: defined as : death, myocardial infarction, and stroke.
Time frame: 36 months
Composite endpoint: defined as : death, myocardial infarction, and stroke.
8 secondary outcomes
All Death
Time frame: 36 months
Cardiac Death
Time frame: 36 months
Myocardial Infarction
Time frame: 36 months
Stroke
Time frame: 36 months
Stent thrombosis (ARC definite/probable)
Time frame: 36 months
Major bleeding event (BARC type 2-5)
Time frame: 36 months
Target Vessel revascularization.
Time frame: 36 months
Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 27585503Cavalcante R, Sotomi Y, Lee CW, Ahn JM, Farooq V, Tateishi H, Tenekecioglu E, Zeng Y, Suwannasom P, Collet C, Albuquerque FN, Onuma Y, Park SJ, Serruys PW. Outcomes After Percutaneous Coronary Intervention or Bypass Surgery in Patients With Unprotected Left Main Disease. J Am Coll Cardiol. 2016 Sep 6;68(10):999-1009. doi: 10.1016/j.jacc.2016.06.024.
- Background: PubMed 28040444Puri R, de la Torre Hernandez JM, Auffret V. Routine Surveillance Coronary Angiography Post-PCI: Should We ReACT and Change Our Routine? JACC Cardiovasc Interv. 2017 Jan 23;10(2):118-120. doi: 10.1016/j.jcin.2016.11.020. Epub 2016 Dec 28. No abstract available.
- Background: PubMed 30155864Aurigemma C, Burzotta F, Porto I, Niccoli G, Leone AM, Crea F, Trani C. Clinical impact of routine angiographic follow-up after percutaneous coronary interventions on unprotected left main. Cardiol J. 2018;25(5):582-588. doi: 10.5603/CJ.a2018.0092. Epub 2018 Aug 29.
- Background: PubMed 27797291Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31.
- Background: PubMed 27810312Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31.
- Background: PubMed 31562798Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM 3rd, Lembo NJ, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman PE, Bochenek A, Schampaert E, Page P, Modolo R, Gregson J, Simonton CA, Mehran R, Kosmidou I, Genereux P, Crowley A, Dressler O, Serruys PW; EXCEL Trial Investigators. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med. 2019 Nov 7;381(19):1820-1830. doi: 10.1056/NEJMoa1909406. Epub 2019 Sep 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiography and Clinical Follow up and Clinical Follow up in people with Coronary Occlusion and Left Main Coronary Artery Disease, run by Fundación EPIC at 30 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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite endpoint: defined as : death, myocardial infarction, and stroke. (time frame: 36 months). 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 NCT04604197, which also lists 6 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 8 Oct 2026.