Coronary Artery DiseaseNCT04859985
The SELUTION DeNovo Study
A study testing SELUTION SLR and DES in people with Coronary Artery Disease, run by M.A. Med Alliance S.A. at 62 sites in 12 countries.
Trial summary
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy. 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?
- SELUTION SLR and DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,326 participants
- Where
- 62 sitesin 12 countries
- Study dates
- 15 May 2021to 31 Oct 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age < 18 years (or 21 according to countries legal age)
- Subject is pregnant or breast-feeding
- Definite or suspected clinically active covid-19 infection
- Subject is under judicial protection, tutorship or curatorship (for France only)
- Subject is unable to fully comply with the study protocol
- Contraindications to dual antiplatelet therapy, sirolimus or its analogues
Show all 19Show fewer
- Presentation with STEMI
- Presentation with NSTEMI and ongoing chest pain or hemodynamic instability
- Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock)
- Chronic NYHA class III or IV heart failure prior to index PCI
- Known LVEF < 30% prior to index PCI
- Previous PCI of a trial target vessel at any time
- Previous PCI of a non-trial target vessel within 30 days
- Trial target lesion located in the left main or any arterial or venous graft
- Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR)
- Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion
- RVD of trial target lesion > 5mm
- Planned major surgery within one month following the procedure
- Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up
Trial locations and contacts
62 sites in 12 countries.
62 sites in 12 countries
Germany14 sites
Universitätsklinik Augsburg
Augsburg
Universitätsklinikum Freiburg
Bad Krozingen
BG Klinikum Unfallkrankenhaus Berlin
Berlin
Charite Campus Virchow Klinikum
Berlin
Kardiologisch-Angiologische Praxis • Herzzentrum Bremen
Bremen
RKH Kliniken Bruchsal Fürst Stirum Klinik
Bruchsal
University Koeln
Cologne
Herzzentrum Dresden GmbH Universitätsklinik
Dresden
Elisabeth-Krankenhaus
Essen
Asklepios Kliniken GmbH & Co.
Hamburg
University Medical Center Hamburg Eppendorf
Hamburg
MEDICLIN Herzzentrum Lahr
Lahr
Johannes Wesling Klinikum Minden
Minden
Herzklinikum Ulm
Ulm
United Kingdom14 sites
The Royal Bournemouth and Christchurch Hospitals
Bournemouth
Royal Sussex County Hospital
Brighton
University Hospitals Bristol
Bristol
Royal Infirmary of Edinburgh
Edinburgh
Golden Jubilee National Hospital
Glasgow
Glenfield Hospital
Leicester
Manchester University NHS Foundation Trust
Manchester
Norfolk and Norwich University Hospitals
Norwich
Trent Cardiac Centre, Nottingham City Hospital
Nottingham
Royal Berkshire Hospital
Reading
Northern General, Sheffield
Sheffield
University Hospital Southampton
Southampton
University Hospitals of North Midlands, Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Worcestershire Royal Hospital
Worcester
France6 sites
CH La Rochelle
La Rochelle
Hôpital Jaques Cartier
Massy
CHU de Nîmes
Nîmes
Hôpital Européen Georges Pompidou
Paris
Centre Hospitalier de Pau
Pau
Clinique Saint Hilaire
Rouen
Switzerland6 sites
University Hospital Basel
Basel
University Hospital of Bern
Bern
Hôpital Cantonal de Fribourg
Fribourg
University Hospital Geneva (HUG)
Geneva
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen
University Zurich
Zurich
Italy4 sites
Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo
Alessandria
Clinica Mediterranea
Naples
Ospedale Santa Croce di Moncalieri
Torino
Ospedale Sant'andrea
Vercelli
Netherlands4 sites
University Medical Center Amsterdam
Amsterdam
University Medical Center Groningen
Groningen
Tergooi MC
Hilversum
UMC Utrecht
Utrecht
Austria3 sites
Academic Teaching Hospital Feldkirch
Feldkirch
University Heart Center Graz
Graz
Kepler Universitätsklinikum GmbH
Linz
Poland3 sites
Szpital Kliniczny Przemienienia Pańskiego UM
Poznan
Kliniczny Szpital Wojewódzki Nr. 2 w Rzeszowie
Rzeszów
Szpital Ministerstwa Spraw Wewnetrznych
Rzeszów
Spain3 sites
Hospital Clinico de Barcelona
Barcelona
Hospital Universitario de La Princesa
Madrid
Hospital Alvaro Cunqueiro, University Hospital of Vigo
Vigo
Czechia2 sites
University Hospital Brno
Brno
University Hospital Ostrava
Ostrava
Singapore2 sites
National Heart Centre Singapore (NHCS)
Singapore
SengKang General Hospital
Singapore
About this study
Official title: Selution DeNovo - A Prospective Randomized, Multi-centre, International, Open Label, Clinical Trial Comparing the Selution DEB Strategy Versus DES Strategy.
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
Read the detailed description
Randomized, multi-centre, international, open label, clinical trial. Patients meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLR DEB or DES.
Patients randomized to the SELUTION SLR DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION DEB group (intention to treat analysis).
Patients randomized to the DES arm will receive treatment using any CE-marked DES, as per standard institutional practice. Patients with failure to deliver DES will be first treated by provisional DEB using the SELUTION DEB, and failing that, with any other device deemed appropriate.
Staged procedures are allowed if they are planned less than 45 days after the index procedure and are done according to the initial treatment allocation for all trial target vessels (DEB if DEB arm, DES if DES arm).
The study will test:
- for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 12 months.
- for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 5 years. If non-inferiority is then established, superiority of the DEB strategy with TVF as an endpoint will be tested.
All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.
- Conditions
- Coronary Artery Disease
- Being tested
- SELUTION SLR, DES
- Keywords
- Drug Eluting Balloon, Coronary, De Novo coronary lesions
- 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.
SELUTION SLRDevice
Patients randomized to the SELUTION SLR™ DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION SLR™ DEB group (intention to treat analysis).
DESDevice
For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.
| Study group | Role | What they receive |
|---|---|---|
| SELUTION SLR DEB | Experimental | Device: SELUTION SLR DEB. For patients randomized to the DEB strategy, all target lesions should be treated with DEB after appropriate lesion preparation, but provisional DES implantation is acceptable if the angiographic result is considered insufficient either after lesion preparation of after DEB treatment (poor flow, dissection type C or higher, residual stenosis > 30%). For bifurcation lesions, when both main and side- branch are considered to require treatment, a DEB should be used for both. Receives: Device: SELUTION SLR |
| DES | Other | Device: Drug Eluting Stent. For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB. Receives: Device: DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
TVF
- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year
Measured: 1 year after treatment
TVF
- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years
Measured: 5 years after treatment
Secondary outcomes (17)
Death or any MI
Cardiac death, non-cardiac death, or any Myocardial Infarction
Measured: 30 days after treatment
CD-TVR
Clinically driven - Target Vessel Revascularization
Measured: 30 days after treatment
TVF
Target Vessel Failure
Measured: 2, 3, 4, 5 years after treatment
Any revascularization
- Target lesion revascularization (TLR) - any and clinically driven
- Target vessel revascularization (TVR) - any and clinically driven
- A new lesion revascularization in a target vessel
- Non-Target vessel revascularization
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Myocardial Infarction (MI)
- Peri-procedural MI
- Target-vessel MI
- Non-target-vessel MI
- MI type (1 to 5) according to the 4th universal definition
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Composite of cardiac death or target vessel MI
Composite of cardiac death or target vessel Myocardial Infarction
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
All-cause mortality
- Cardiac mortality
- Non-cardiac mortality
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Patient-oriented ARC-2 composite endpoint
- All-cause mortality
- Any stroke
- Any MI (includes non-target vessel territory)
- Any revascularization
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Site-reported stroke
Site-reported stroke
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Site-reported BARC 3-5 Bleeding
Site-reported BARC (Bleeding Academic Research Consortium ) 3-5 Bleeding
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Total costs of materials used during treatment
Measured: 1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Time of procedure. Total minutes from patient introducer introduction until removal
Measured: 1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Total hospitalization days per procedure.
Measured: 1, 2, 3, 4 and 5 years after treatment
Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding
Net clinical benefit, a combination of freedom from (Target Vessel Failure) TVF and/or BARC 3-5 bleeding
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Device success
Device success defined as achievement of a final residual diameter stenosis of < 30% (site-reported), using the assigned device only
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Lesion success
Lesion success defined as achievement of < 30% residual stenosis (site-reported), using any PCI method
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Procedure success
Procedure success defined as achievement of a final diameter stenosis of < 30% (site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay
Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start15 May 2021
- Primary completion15 Sep 2025
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 3,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.A. Med Alliance S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859985
- Sponsor's protocol ID
- S2021-02
- Status last verified
- Jan 2026
- First submitted
- 23 Mar 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spaulding C, Krackhardt F, Bogaerts K, Abdelaal E, Alfonso F, Briguori C, Bruch L, Cruden N, Den Hartog AW, Garot P, Godin M, Hildick-Smith D, Johnson T, Ladwiniec A, Linke A, Maart CA, Mashayekhi K, Meier P, Meunier L, Morgan K, O'Kane P, Puymirat E, Rissanen TT, Sabate M, Schmitz T, Toth GG, Trevelyan J, Wanczura P, Wiemer M, Wykrzykowska JJ, Urban P, Eccleshall S; SELUTION DeNovo Investigators. Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial. Circulation. 2026 Jul 21;154(3):185-197. doi: 10.1161/CIRCULATIONAHA.126.079033. Epub 2026 Jun 15.
PubMed 42290366Spaulding C, Krackhardt F, Bogaerts K, Urban P, Meis S, Morice MC, Eccleshall S. Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. Am Heart J. 2023 Apr;258:77-84. doi: 10.1016/j.ahj.2023.01.007. Epub 2023 Jan 13.
PubMed 36642225
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selution DeNovo - A Prospective Randomized, Multi-centre, International, Open Label, Clinical Trial Comparing the Selution DEB Strategy Versus DES Strategy.
- ClinicalTrials.gov ID
- NCT04859985
- Acronym / sponsor ID
- S2021-02
- Conditions
- Coronary Artery Disease
- Keywords
- Drug Eluting Balloon, Coronary, De Novo coronary lesions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,326 participants (actual)
- Lead sponsor
- M.A. Med Alliance S.A.Industry (pharma, biotech, devices)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 26 Apr 2021 (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.
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
Detailed description
Randomized, multi-centre, international, open label, clinical trial. Patients meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLR DEB or DES.
Patients randomized to the SELUTION SLR DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION DEB group (intention to treat analysis).
Patients randomized to the DES arm will receive treatment using any CE-marked DES, as per standard institutional practice. Patients with failure to deliver DES will be first treated by provisional DEB using the SELUTION DEB, and failing that, with any other device deemed appropriate.
Staged procedures are allowed if they are planned less than 45 days after the index procedure and are done according to the initial treatment allocation for all trial target vessels (DEB if DEB arm, DES if DES arm).
The study will test:
- for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 12 months.
- for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 5 years. If non-inferiority is then established, superiority of the DEB strategy with TVF as an endpoint will be tested.
All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| SELUTION SLR DEB | Experimental | Device: SELUTION SLRDevice: SELUTION SLR DEB. For patients randomized to the DEB strategy, all target lesions should be treated with DEB after appropriate lesion preparation, but provisional DES implantation is acceptable if the angiographic result is considered insufficient either after lesion preparation of after DEB treatment (poor flow, dissection type C or higher, residual stenosis > 30%). For bifurcation lesions, when both main and side- branch are considered to require treatment, a DEB should be used for both. |
| DES | Other | Device: DESDevice: Drug Eluting Stent. For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Age < 18 years (or 21 according to countries legal age)
- Subject is pregnant or breast-feeding
- Definite or suspected clinically active covid-19 infection
- Subject is under judicial protection, tutorship or curatorship (for France only)
- Subject is unable to fully comply with the study protocol
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 |
|---|---|---|
| SELUTION SLRPatients randomized to the SELUTION SLR™ DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION SLR™ DEB group (intention to treat analysis). | Device | SELUTION SLR DEB |
| DESFor patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB. | Device | DES |
Primary outcome
TVF
Time frame: 1 year after treatment
- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year
TVF
Time frame: 5 years after treatment
- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years
17 secondary outcomes
Death or any MI
Time frame: 30 days after treatment
CD-TVR
Time frame: 30 days after treatment
TVF
Time frame: 2, 3, 4, 5 years after treatment
Any revascularization
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Myocardial Infarction (MI)
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Composite of cardiac death or target vessel MI
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
All-cause mortality
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Patient-oriented ARC-2 composite endpoint
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Site-reported stroke
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Site-reported BARC 3-5 Bleeding
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Time frame: 1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Time frame: 1, 2, 3, 4 and 5 years after treatment
Cost-effectiveness of DEB vs. DES after 12 months in selected countries
Time frame: 1, 2, 3, 4 and 5 years after treatment
Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Device success
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Lesion success
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
Procedure success
Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment
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 22 Jan 2026.
- Derived from this study: PubMed 42290366Spaulding C, Krackhardt F, Bogaerts K, Abdelaal E, Alfonso F, Briguori C, Bruch L, Cruden N, Den Hartog AW, Garot P, Godin M, Hildick-Smith D, Johnson T, Ladwiniec A, Linke A, Maart CA, Mashayekhi K, Meier P, Meunier L, Morgan K, O'Kane P, Puymirat E, Rissanen TT, Sabate M, Schmitz T, Toth GG, Trevelyan J, Wanczura P, Wiemer M, Wykrzykowska JJ, Urban P, Eccleshall S; SELUTION DeNovo Investigators. Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial. Circulation. 2026 Jul 21;154(3):185-197. doi: 10.1161/CIRCULATIONAHA.126.079033. Epub 2026 Jun 15.
- Derived from this study: PubMed 36642225Spaulding C, Krackhardt F, Bogaerts K, Urban P, Meis S, Morice MC, Eccleshall S. Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. Am Heart J. 2023 Apr;258:77-84. doi: 10.1016/j.ahj.2023.01.007. Epub 2023 Jan 13.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SELUTION SLR and DES in people with Coronary Artery Disease, run by M.A. Med Alliance S.A. at 62 sites in 12 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 0 inclusion and 19 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Germany, United Kingdom, France, Switzerland, Italy and 7 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.
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?
TVF (time frame: 1 year after treatment). The study lists 2 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 NCT04859985, which also lists 2 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 22 Jan 2026.