Coronary Artery DiseasePhase 4NCT04137510
Bioflow-DAPT Study
A Phase 4 study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Biotronik AG at 53 sites in 18 countries.
Trial summary
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,948 participants
- Where
- 53 sitesin 18 countries
- Study dates
- 24 Feb 2020to 20 Sep 2022
- Phase
- Phase 4
- 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
- Subject is acceptable candidate for treatment with a DES
- Subject is considered at high bleeding risk (HBR), defined as meeting one or more of the following criteria at the time of enrollment:
- ≥ 75 years of age
- Moderate (estimated GFR 30-59 ml/min) or severe (estimated GFR < 30 ml/min) chronic kidney disease or failure (dialysis dependent)
- Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices.
- Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated
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- Anemia with hemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization
- Baseline thrombocytopenia defined as a platelet count <100,000/mm3
- History of stroke (ischemic or hemorrhagic), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a brain arteriovenous malformation
- History of hospitalization for bleeding within the previous 12 months
- Chronic clinically significant bleeding diathesis
- Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC)
- Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin
- Nondeferrable major surgery on DAPT
- Recent major surgery or major trauma within 30 days before PCI
- Precise DAPT score ≥ 25
- Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrollment
- Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
- Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month
- Subject is eligible for dual antiplatelet therapy treatment with aspirin plus a P2Y12 inhibitor agent for 1-month post index procedure
Who cannot join
- Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel
- Subject has a known allergy to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), molybdenum, platinum and irridium, silicon carbide, PLLA,polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media
- Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 72 hours prior to or during the index procedure
- 4. Subject with documented left ventricular ejection fraction (LVEF) <30% as evaluated by the most recent imaging exam (i.e. echocardiogram, ventriculogram, MUGA, etc.), but within 90 days pre/procedure or during the index procedure
- Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT
- Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor and/or aspirin within the first month post-index procedure Note - planned staged procedure at the time of index procedure is not allowed
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- Active bleeding at the time of inclusion
- Subject with a current medical condition with a life expectancy of less than 12 months
- Subject is currently participating or intends to participate in another investigational drug or device trial within 12 months following the index procedure or any other clinical trial that may interfere with the treatment or protocol of this study
- Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
- In the investigator's opinion, subject will not be able to comply with the follow-up requirements
- Subjects who need an impartial witness to give an informed consent
Trial locations and contacts
53 sites in 18 countries.
53 sites in 18 countries
France10 sites
CHU Brest
Brest, 29601
Centre Hospitalier Universitaire de Lille
Lille, 59000
Hopital Privé Jacques Cartier
Massy, 91300
CHU Nimes
Nîmes, 30029
Assistance Publique Hopitaux de Paris (APHP)
Paris, 75004
Assistance Publique Hopitaux de Paris
Paris, 75004
Clinique Saint Hilaire
Rouen, 76000
Clinique Pasteur
Toulouse, 31076
CHU de Toulouse
Toulouse, 31400
CHRU de Tours
Tours, 37044
Germany5 sites
Segeberger Kliniken
Bad Segeberg, 23795
Charite Virchow-Klinikum
Berlin, 13353
Contilla Herz- und Gefäßzentrum, Elisabeth-Krankenhaus
Essen, 45138
Klinikum Friedrichshafen GmbH
Friedrichshafen, 88048
Städtische Kliniken Neuss, Lukaskrankenhaus GmbH
Neuss, 41464
Switzerland5 sites
Hôpitaux Universitaires de Genève
Geneva, 1211
Centre Hospitalier Universitaires Vaudoise
Lausanne, 1011
CardioCentro Ticino
Lugano, 6900
Hôpital de Morges
Morges, 1110
Stadtspital Triemli
Zurich, 8063
Belgium4 sites
AZ St Jan Brugge
Bruges, 8000
Ziekenhuis Oost Limburg Genk
Genk, 3600
AZ Delta
Roeselare, 8800
UCL St Luc
Woluwe-Saint-Lambert, 1200
Italy4 sites
Azienda Ospedaliero - Universitaria Policlinico - Vittorio
Catania, 95125
Centro Cardiologico Monzino
Milan, 20138
IRCCS Fondazione Policlinico "San Matteo"
Pavia, 27100
Azienda Ospedaliero-Universitaria
Torrette, 60126
Australia3 sites
The Northern Hospital
Epping, 3076
John Hunter Hospital
New Lambton, 2305
Royal Perth Hospital
Perth, 6000
Hungary3 sites
Semmelweis University
Budapest, 1124
Somogy County Kaposi Mór Teaching Hospital
Kaposvár, 7400
University of Pécs
Pécs, 7624
Spain3 sites
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Clinico Universitario de la Valencia
Valencia, 46010
Hospital Universitario Araba
Vitoria-Gasteiz, 01009
Austria2 sites
Medizinische Universität Graz
Graz, 8036
Uniklinikum Salzburg
Salzburg, 5020
Denmark2 sites
Herlev og Gentofte Hospital
Hellerup, 2900
Roskilde University Hospital
Roskilde, 4000
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
The Chinese University of Hong Kong
Shatin
Latvia2 sites
Sia AK Medical Solutions
Engure, LV-3113
Pauls Stradins Clinical University Hospital
Riga, 1002
Poland2 sites
Krakowski Szpital Specjalistyczny im. Jana Pawla
Krakow, 31-202
Miedziowe Centrum Zdrowia
Lubin, 59-301
Thailand2 sites
Phramongkutklao Hospital
Bangkok, 10400
Central Chest Institute of Thailand
Bangkok, 11000
About this study
Official title: A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.
A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.
Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention
- Keywords
- DAPT, Dual antiplatelet therapy, high bleeding risk, HBR, Coronary artery disease, Percutaneous coronary intervention, PCI
- 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.
Percutaneous coronary interventionDevice
It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel.
| Study group | Role | What they receive |
|---|---|---|
| Orsiro | Experimental | Not described Receives: Device: Percutaneous coronary intervention |
| Resolute Onyx | Active comparator | Not described Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months
Measured: 12 months post-procedure
Secondary outcomes (15)
Rate of definite/probable stent thrombosis according to the ARC definition
Measured: until 12 months post-procedure
Rate of MACCE
composite of all-cause death, MI, and stroke
Measured: until 12 months post-procedure
Rate of MACE
composite of cardiac death, MI, and Target Vessel Revascularization (TVR)
Measured: until 12 months post-procedure
Rate of cardiac death or MI
all, target vessel related MI, Q-wave and non Q-wave, ST-related and non ST-related
Measured: until 12 months post-procedure
Rate of all-cause death, cardiac, non-cardiac
Measured: until 12 months post-procedure
Rate of stroke, ischemic and hemorrhagic
Measured: until 12 months post-procedure
Rate of clinically-indicated TVR
Measured: until 12 months post-procedure
Rate of clinically-indicated Target Lesion Revascularization (TLR)
Measured: until 12 months post-procedure
Rate of Target Vessel Failure (TVF)
Composite of clinically-driven TVR, cardiac death or target-vessel related MI
Measured: until 12 months post-procedure
Rate of target lesion failure (TLF)
Composite of clinically driven TLR, cardiac death or target vessel related MI
Measured: until 12 months post-procedure
Rate of bleeding according to BARC definition
Measured: until 12 months post-procedure
Rate of bleeding according to GUSTO definition
Measured: until 12 months post-procedure
Rate of bleeding according to TIMI definition
Measured: until 12 months post-procedure
Rate of Device success
Attainment of less than 30% residual stenosis of the target lesion using assigned stent only
Measured: until 12 months post-procedure
Rate of Procedure success
Attainment of less than 30% residual stenosis of the target lesion using assigned stent only without occurrence of in-hospital major adverse cardiac events
Measured: until 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start24 Feb 2020
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-center, international, two-arm randomized controlled clinical study.
- Masking
- None (open label)
- Enrolment
- 1,948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Valgimigli, Prof. Dr., Principal investigator, Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137510
- Sponsor's protocol ID
- C1703
- Status last verified
- Apr 2023
- First submitted
- 22 Oct 2019
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mankerious N, Hemetsberger R, Wlodarczak A, Merkely B, Kelbaek H, Cayla G, Legutko J, Galli S, Godin M, Toth GG, Lhermusier T, Saad M, Honton B, Sanguineti F, Dietrich PL, Frank D, Stammen F, Ferdinande B, Silvain J, Capodanno D, Nef H, Richardt G, Toelg R, Valgimigli M. Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial. Eur Heart J Acute Cardiovasc Care. 2026 Aug 5:zuag089. doi: 10.1093/ehjacc/zuag089. Online ahead of print.
PubMed 42555546Valgimigli M, Wlodarczak A, Tolg R, Merkely B, Kelbaek H, Legutko J, Galli S, Godin M, Toth GG, Lhermusier T, Honton B, Dietrich PL, Stammen F, Ferdinande B, Silvain J, Capodanno D, Cayla G; Bioflow-DAPT Investigators. Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial. Circulation. 2023 Sep 26;148(13):989-999. doi: 10.1161/CIRCULATIONAHA.123.065448. Epub 2023 Aug 25.
PubMed 37624364Landi A, Wlodarczak A, Tolg R, Kelbaek H, Legutko J, Galli S, Godin M, Toth GG, Lhermusier T, Honton B, Dietrich PL, Stammen F, Ferdinande B, Silvain J, Capodanno D, Cayla G, Valgimigli M; BIOFLOW-DAPT investigators. Design and Rationale of the BIOFLOW-DAPT Trial: a Prospective, Randomized, Multicenter Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination with 1-Month Dual Antiplatelet Therapy. J Cardiovasc Transl Res. 2023 Oct;16(5):1135-1143. doi: 10.1007/s12265-023-10400-x. Epub 2023 Jun 1.
PubMed 37264295Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028. No abstract available.
PubMed 34503738
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)
- ClinicalTrials.gov ID
- NCT04137510
- Acronym / sponsor ID
- C1703
- Conditions
- Coronary Artery Disease
- Keywords
- DAPT, Dual antiplatelet therapy, high bleeding risk, HBR, Coronary artery disease, Percutaneous coronary intervention, PCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,948 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 24 Oct 2019 (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.
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.
A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.
Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multi-center, international, two-arm randomized controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Orsiro | Experimental | Device: Percutaneous coronary intervention |
| Resolute Onyx | Active comparator | Device: Percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject is acceptable candidate for treatment with a DES
- Subject is considered at high bleeding risk (HBR), defined as meeting one or more of the following criteria at the time of enrollment:
- Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrollment
- Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
- Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month
Key exclusion criteria (12 listed)
- Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel
- Subject has a known allergy to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), molybdenum, platinum and irridium, silicon carbide, PLLA,polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media
- Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 72 hours prior to or during the index procedure
- 4. Subject with documented left ventricular ejection fraction (LVEF) <30% as evaluated by the most recent imaging exam (i.e. echocardiogram, ventriculogram, MUGA, etc.), but within 90 days pre/procedure or during the index procedure
- Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT
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 interventionIt's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel. | Device | Orsiro, Resolute Onyx |
Primary outcome
Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months
Time frame: 12 months post-procedure
15 secondary outcomes
Rate of definite/probable stent thrombosis according to the ARC definition
Time frame: until 12 months post-procedure
Rate of MACCE
Time frame: until 12 months post-procedure
Rate of MACE
Time frame: until 12 months post-procedure
Rate of cardiac death or MI
Time frame: until 12 months post-procedure
Rate of all-cause death, cardiac, non-cardiac
Time frame: until 12 months post-procedure
Rate of stroke, ischemic and hemorrhagic
Time frame: until 12 months post-procedure
Rate of clinically-indicated TVR
Time frame: until 12 months post-procedure
Rate of clinically-indicated Target Lesion Revascularization (TLR)
Time frame: until 12 months post-procedure
Rate of Target Vessel Failure (TVF)
Time frame: until 12 months post-procedure
Rate of target lesion failure (TLF)
Time frame: until 12 months post-procedure
Rate of bleeding according to BARC definition
Time frame: until 12 months post-procedure
Rate of bleeding according to GUSTO definition
Time frame: until 12 months post-procedure
Rate of bleeding according to TIMI definition
Time frame: until 12 months post-procedure
Rate of Device success
Time frame: until 12 months post-procedure
Rate of Procedure success
Time frame: until 12 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 42555546Mankerious N, Hemetsberger R, Wlodarczak A, Merkely B, Kelbaek H, Cayla G, Legutko J, Galli S, Godin M, Toth GG, Lhermusier T, Saad M, Honton B, Sanguineti F, Dietrich PL, Frank D, Stammen F, Ferdinande B, Silvain J, Capodanno D, Nef H, Richardt G, Toelg R, Valgimigli M. Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial. Eur Heart J Acute Cardiovasc Care. 2026 Aug 5:zuag089. doi: 10.1093/ehjacc/zuag089. Online ahead of print.
- Derived from this study: PubMed 37624364Valgimigli M, Wlodarczak A, Tolg R, Merkely B, Kelbaek H, Legutko J, Galli S, Godin M, Toth GG, Lhermusier T, Honton B, Dietrich PL, Stammen F, Ferdinande B, Silvain J, Capodanno D, Cayla G; Bioflow-DAPT Investigators. Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial. Circulation. 2023 Sep 26;148(13):989-999. doi: 10.1161/CIRCULATIONAHA.123.065448. Epub 2023 Aug 25.
- Derived from this study: PubMed 37264295Landi A, Wlodarczak A, Tolg R, Kelbaek H, Legutko J, Galli S, Godin M, Toth GG, Lhermusier T, Honton B, Dietrich PL, Stammen F, Ferdinande B, Silvain J, Capodanno D, Cayla G, Valgimigli M; BIOFLOW-DAPT investigators. Design and Rationale of the BIOFLOW-DAPT Trial: a Prospective, Randomized, Multicenter Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination with 1-Month Dual Antiplatelet Therapy. J Cardiovasc Transl Res. 2023 Oct;16(5):1135-1143. doi: 10.1007/s12265-023-10400-x. Epub 2023 Jun 1.
- Derived from this study: PubMed 34503738Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028. No abstract available.
- Individual participant dataSharing planned: No
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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.
Marco Valgimigli, Prof. Dr. principal investigator
Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland
53 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Biotronik AG at 53 sites in 18 countries.
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 20 inclusion and 12 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: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France, Germany, Switzerland, Belgium, Italy and 13 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months (time frame: 12 months post-procedure). 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 NCT04137510, which also lists 4 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 7 Jun 2024.