Coronary Artery DiseaseSPAGONCT06373601
SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
A study testing sirolimus-eluting balloon (Selution) and paclitaxel-eluting balloon (SeQuent Please Neo) in people with Coronary Artery Disease and Stenosis Coronary, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 10 sites in Italy.
Trial summary
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Stenosis Coronary, Coronary Artery Lesion
- What is being tested?
- sirolimus-eluting balloon (Selution) and paclitaxel-eluting balloon (SeQuent Please Neo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 10 sitesItaly
- Study dates
- 5 Sep 2024to 1 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥18 years
- Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values.
- The subject has at least one de-novo lesion in a small vessel (>2.00 mm and ≤3.00 mm prior to pre-dilatation) with a diameter stenosis between 50% and 99% (prior to pre-dilatation). It is possible to enroll subjects that have a stent previously implanted in the same epicardial territory (main vessel and ramifications) of the target lesion
- Patients with target lesion to be treated with DCB < 30 mm in length (up to 40 patients) or with DCB ≥ 30 mm in length (at least 100 patients)
- Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up
- Subject must have completed the follow-up phase of any previous study
Who cannot join
- Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
- Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
- Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor
- Subjects who experienced a previous PCI with DCB in the epicardial territory (main vessel and ramifications) where the target lesion is located, during the last 12 months
- Subject suffered from stroke/TIA during the last 6 months
- LVEF <30%
Show all 24Show fewer
- Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
- Known renal insufficiency (e.g. serum creatinine >2,5 mg/dL, creatinine clearance ≤30 mL/min or eGFR ≤30 mL/min/m2), or subject on dialysis, or acute kidney failure (as per physician judgment)
- Subject undergoing planned surgery within 1 month with the necessity to stop DAPT
- History of bleeding diathesis or coagulopathy
- The subject is a recipient of a heart transplant
- Concurrent medical condition with a life expectancy of less than 12 months
- The subject is unwilling/not able to return for angiographic re-catheterisation at 12 months follow-up
- Currently participating in another trial
- Angiographic exclusion criteria:
- Target vessel size >3.00 mm
- Target vessel size ≤2.00 mm
- Target lesion has a diameter stenosis < 50% prior to pre-dilatation
- Target lesion has a total occlusion or TIMI flow < 2 prior to pre-dilatation
- Pre-dilatation of the target lesion not performed or not successful (residual stenosis > 30%, TIMI flow < 3 and presence of major angiographic dissections)
- Target lesion in left main stem
- The target vessel contains visible thrombus
- Aorto-ostial target lesion (within 3 mm of the aorta junction)
- Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Riccardo RF Falzone contact
10 sites in 1 country
Italy10 sites, 9 recruiting
- Recruiting
ASST Papa Giovanni XXIII
Bergamo, Italy/Bergamo, 24127
Luigi Fiocca, MD, 0352674570, luigifiocca@gmail.com
- Recruiting
Fondazione Poliambulanza
Brescia, Italy/Brescia, 25124
Diego Maffeo, MD, 0303518983, diego.maffeo@poliambulanza.it
- Withdrawn
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy/Ferrara, 44124
- Recruiting
Clinica Montevergine
Mercogliano, Italy/Avellino, 83013
Tullio Tesorio, MD, 0825 7051130, tulliotesorio@gmail.com
- Recruiting
Centro Cardiologico Monzino
Milan, Italy/Milano, 20138
Stefano Galli, MD, 0258002533, stefano.galli@cardiologicomonzino.it
- Recruiting
Clinica Mediterranea
Naples, Italy/Napoli, 80122
Carlo Briguori, MD, 0817259704, carlo.briguori@gmail.com
- Recruiting
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, Italy/Torino, 10043
Marco Pavani, MD, 011 9551425, marcopavani@alice.it
- Recruiting
Ospedale di Rivoli
Rivoli, Italy/Torino, 10098ù
Alfonso Franzè, MD, 0119026803, emodinamica@sanluigi.piemonte.it
Ferdinando Varbella, MD
- Recruiting
Istituto Clinico Humanitas
Rozzano, Italy/Milano, 20089
Antonio Mangieri, MD, 0282244330, antonio.mangieri@gmail.com
- Not yet recruiting
Ospedale Sant'Andrea
Vercelli, Italy/Vercelli, 13100
Fabrizio Ugo, MD, 0161593124, ugo.fabrizio@libero.it
About this study
Official title: Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional Flow Reserve (FFR) at 12 months follow-up.
Read the detailed description
This is a prospective, randomized, multicenter, no-profit and post-market study in subjects with small vessels, i.e. at least one de novo lesion in a small vessel (>2.00 mm and ≤3.00). Vessel size is evaluated by visual estimation. It is possible to include only one study lesion per patient. For the purposes of this study, in cases of diffuse coronary artery disease where overlapped DCB are utilized for the treatment of the lesion, this will be considered as a single lesion. In case of a successful predilatation (i.e. no major (type D, E, F) angiographic dissections, residual stenosis ≤ 30% and TIMI flow = 3), the subject will be randomized in a 1:1 fashion to SelutionTM or SeQuent Please NeoTM. Randomization will be stratified according to DCB length (< 30 mm or ≥ 30 mm) in order to include at least 100 patients treated with DCB of 30 mm or longer. Measurements of intramyocardial resistances, after lesion preparation prior to DCB treatment and after DCB treatment (2 measurements), will be limited to a maximum of 100 lesions treated with DCB ≥ 30 mm. Given the lack of literature data on intramyocardial resistance measurements, a minimum of 100 subjects is considered necessary to provide an initial evaluation of these parameters. With a total sample size of 140 patients for the study, it will be allowed to enroll up to 40 patients treated with DCB < 30 mm. Once this limit is reached, only patients treated with DCB ≥ 30 mm will be enrolled while maintaining a 1:1 randomization ratio. During the index procedure, it is possible to treat other not study lesions (if applicable) with any other commercial device (e.g. drug-eluting stent) if they are located in a different epicardial territory than the study target lesion. All not studylesions should be treated prior to study target lesion procedure, and should be successful and uncomplicated.
Follow-up by phone call will occur at 1 and 6 months post-PCI. At 12 months all subjects will perform an angiographic follow up at the same site where the index procedure was performed. Quantitative Coronary Angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and on follow up angiography by the imaging core lab. FFR assessment will be performed at the time of follow-up angiography.
All subjects must receive dual anti-platelet therapy (DAPT), being aspirin (ASA) and P2Y12 inhibition therapy for at least 1 month after drug coated balloon PCI or according to standard local practice (with the choice of agent left to the discretion of the investigator), followed by ASA monotherapy indefinitely. However, in case the subject had recent ACS or is receiving additional drug-eluting stents, DAPT must be given according to local standard of care.
- Conditions
- Coronary Artery Disease, Stenosis Coronary, Coronary Artery Lesion, Percutaneous Coronary Intervention
- Being tested
- sirolimus-eluting balloon (Selution), paclitaxel-eluting balloon (SeQuent Please Neo)
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus-eluting balloon (Selution)Device
PCI treatment with DCB, in particular sirolimus coated balloon
paclitaxel-eluting balloon (SeQuent Please Neo)Device
PCI treatment with DCB, in particular paclitaxel coated balloon
| Study group | Role | What they receive |
|---|---|---|
| sirolimus-eluting balloon (Selution) | Experimental | DCB angioplasty with a sirolimus-eluting balloon Receives: Device: sirolimus-eluting balloon (Selution) |
| paclitaxel-eluting balloon (SeQuent Please Neo) | Active comparator | DCB angioplasty with a paclitaxel-eluting balloon Receives: Device: paclitaxel-eluting balloon (SeQuent Please Neo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure
The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure. Net Gain is defined as acute gain at the time of the index procedure minus late loss at the time of follow-up angiography.
Measured: 12 months post-procedure
Fractional Flow Reserve (FFR)
FFR (absolute value) at 12 months post-procedure
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (13)
Device success (lesion based)
Successful delivery and inflation within 45 seconds of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of <30%. I
Measured: 12 months post-procedure
Procedure success
Successful delivery and inflation within 45 seconds of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of <30 % without the occurrence of TLF during the index procedure hospital stay).
Measured: 12 months post-procedure
Angiographic outcomes 1
late lumen loss
Measured: 12 months post-procedure
Angiographic outcomes 2
minimal lumen diameter
Measured: 12 months post-procedure
Angiographic outcomes 3
percent diameter stenosis
Measured: 12 months post-procedure
Angiographic outcomes 4
restenosis rate
Measured: 12 months post-procedure
Device oriented Composite Endpoint (DoCE/ TLF)
DoCE/ TLF which is composite of cardiac death, TV-MI, and clinically indicated target lesion revascularization (TLR)
Measured: 12 months post-procedure
Acute/subacute/early/late vessel thrombosis
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the patient left the catheterization lab.
Measured: 12 months post-procedure
Periprocedural myocardial infarction
Periprocedural myocardial infarction according to the Fourth Universal definition of Myocardial Infarction
Measured: From enrollment to the end of treatment at 12 months
PCI related myocardial injury
PCI related myocardial injury, defined according to the Fourth Universal definition of Myocardial Infarction estimating the absolute value of troponin pre-discharge or within 3-8 hours post-PCI
Measured: From enrollment to the end of treatment at 12 months
Absolute difference in CFR for the first 100 patients treated with DCB ≥ 30 mm
Absolute difference in CFR measured with a dedicated system (PressureWire™ X Guidewire and Coroventis CoroFlow Cardiovascular System, Abbott)
Measured: baseline
Absolute variation in IMR for the first 100 patients treated with DCB ≥ 30 mm
Absolute variation in IMR from the first assessment (after predilation) to the second assessment (after DCB angioplasty)
Measured: baseline
Absolute decrease in CFR for the first 100 patients treated with DCB ≥ 30 mm
Absolute decrease in CFR from the first assessment (after predilatation) to the second assessment (after DCB angioplasty)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start5 Sep 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)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
- 140 subjects will be enrolled in a competitive way and 1:1 randomized to receive treatment with either the study device (SelutionTM) or the control device (SeQuent Please NeoTM). Randomization will be stratified according to DCB length: at least 100 patients treated with DCB ≥ 30 mm will be assigned to either SelutionTM or SeQuent Please NeoTM, while a maximum of 40 patients treated with DCB \< 30 mm will be assigned to either SelutionTM or SeQuent Please NeoTM. A minimum of 100 subjects treated with DCB ≥ 30 mm is considered necessary to provide an initial evaluation of intramyocardial resistance measurements, due to the lack of literature data on these parameters.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio AC Colombo, MD, Study chair, Fondazione Evidence ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373601
- Sponsor's protocol ID
- SPAGO
- Acronym
- SPAGO
- Status last verified
- Nov 2025
- First submitted
- 4 Apr 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duan Y, Wang Y, Zhang M, Li Z, Chen L, Miao H, Pei S, Lu Y, Wang Z. Computational Pressure-Fluid Dynamics Applied to Index of Microcirculatory Resistance, Predicting the Prognosis of Drug-Coated Balloons Compared With Drug-Eluting Stents in STEMI Patients. Front Physiol. 2022 May 24;13:898659. doi: 10.3389/fphys.2022.898659. eCollection 2022.
PubMed 35685283Nishi T, Murai T, Ciccarelli G, Shah SV, Kobayashi Y, Derimay F, Waseda K, Moonen A, Hoshino M, Hirohata A, Yong ASC, Ng MKC, Amano T, Barbato E, Kakuta T, Fearon WF. Prognostic Value of Coronary Microvascular Function Measured Immediately After Percutaneous Coronary Intervention in Stable Coronary Artery Disease: An International Multicenter Study. Circ Cardiovasc Interv. 2019 Sep;12(9):e007889. doi: 10.1161/CIRCINTERVENTIONS.119.007889. Epub 2019 Sep 6.
PubMed 31525096Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23.
PubMed 12821539Del Buono MG, Montone RA, Camilli M, Carbone S, Narula J, Lavie CJ, Niccoli G, Crea F. Coronary Microvascular Dysfunction Across the Spectrum of Cardiovascular Diseases: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Sep 28;78(13):1352-1371. doi: 10.1016/j.jacc.2021.07.042.
PubMed 34556322Colleran R, Harada Y, Kufner S, Giacoppo D, Joner M, Cassese S, Ibrahim T, Laugwitz KL, Kastrati A, Byrne RA. Changes in high-sensitivity troponin after drug-coated balloon angioplasty for drug-eluting stent restenosis. EuroIntervention. 2017 Oct 20;13(8):962-969. doi: 10.4244/EIJ-D-16-00939.
PubMed 28134126Ikenaga H, Kurisu S, Ishibashi K, Dohi Y, Fukuda Y, Kihara Y. Slow-flow phenomenon after Paclitaxel-coated balloon angioplasty: findings from optical coherence tomography and coronary angioscopy. JACC Cardiovasc Interv. 2015 Apr 20;8(4):e59-62. doi: 10.1016/j.jcin.2014.11.016. Epub 2015 Mar 26. No abstract available.
PubMed 25819189Young M, Cuculi F, Erne P. PTCA with drug-coated balloons is associated with immediate decrease of coronary flow reserve. Catheter Cardiovasc Interv. 2013 Mar;81(4):682-6. doi: 10.1002/ccd.23502. Epub 2013 Jan 29.
PubMed 23361864Aihara K, Torii S, Ito M, Koseki K, Shiozaki M, Sato Y, Nakamura N, Yoshikawa A, Ikari Y, Nakazawa G. Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model. EuroIntervention. 2024 Mar 18;20(6):e389-e398. doi: 10.4244/EIJ-D-23-00425.
PubMed 38506736Kawai K, Rahman MT, Nowicki R, Kolodgie FD, Sakamoto A, Kawakami R, Konishi T, Virmani R, Labhasetwar V, Finn AV. Efficacy and Safety of Dual Paclitaxel and Sirolimus Nanoparticle-Coated Balloon. JACC Basic Transl Sci. 2024 May 1;9(6):774-789. doi: 10.1016/j.jacbts.2024.02.002. eCollection 2024 Jun.
PubMed 39070273Boitet A, Grassin-Delyle S, Louedec L, Dupont S, Lamy E, Coggia M, Michel JB, Coscas R. An Experimental Study of Paclitaxel Embolisation During Drug Coated Balloon Angioplasty. Eur J Vasc Endovasc Surg. 2019 Apr;57(4):578-586. doi: 10.1016/j.ejvs.2018.11.019. Epub 2019 Mar 11.
PubMed 30871939Nakamura R, Torii S, Kato T, Kawasaki D. A Case of Vasculitis Due to Distal Particulate Embolization After Use of Drug-Coated Balloon. JACC Cardiovasc Interv. 2022 Jul 25;15(14):1486-1487. doi: 10.1016/j.jcin.2022.05.030. Epub 2022 Jun 29. No abstract available.
PubMed 35780056Torii S, Yahagi K, Mori H, Harari E, Romero ME, Kolodgie FD, Young B, Ragheb A, Virmani R, Finn AV. Biologic Drug Effect and Particulate Embolization of Drug-Eluting Stents versus Drug-Coated Balloons in Healthy Swine Femoropopliteal Arteries. J Vasc Interv Radiol. 2018 Jul;29(7):1041-1049.e3. doi: 10.1016/j.jvir.2018.02.006. Epub 2018 May 10.
PubMed 29754850Torii S, Jinnouchi H, Sakamoto A, Romero ME, Kolodgie FD, Virmani R, Finn AV. Comparison of Biologic Effect and Particulate Embolization after Femoral Artery Treatment with Three Drug-Coated Balloons in Healthy Swine Model. J Vasc Interv Radiol. 2019 Jan;30(1):103-109. doi: 10.1016/j.jvir.2018.07.025. Epub 2018 Dec 7.
PubMed 30527654Milewski K, Afari ME, Tellez A, Aboodi MS, Kim JS, Cheng Y, Conditt GB, McGregor JC, Yi GH, Stenoien M, Langanki D, Krueger CG, Kaluza GL, Granada JF. Evaluation of efficacy and dose response of different paclitaxel-coated balloon formulations in a novel swine model of iliofemoral in-stent restenosis. JACC Cardiovasc Interv. 2012 Oct;5(10):1081-8. doi: 10.1016/j.jcin.2012.06.012.
PubMed 23078739Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.
PubMed 31126887
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selution Sirolimus Coated Balloon (MedAlliance) Versus SeQuent Please Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Medium-small Size Vessels.
- ClinicalTrials.gov ID
- NCT06373601
- Acronym / sponsor ID
- SPAGO / SPAGO
- Conditions
- Coronary Artery Disease, Stenosis Coronary, Coronary Artery Lesion, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUSUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional Flow Reserve (FFR) at 12 months follow-up.
Detailed description
This is a prospective, randomized, multicenter, no-profit and post-market study in subjects with small vessels, i.e. at least one de novo lesion in a small vessel (>2.00 mm and ≤3.00). Vessel size is evaluated by visual estimation. It is possible to include only one study lesion per patient. For the purposes of this study, in cases of diffuse coronary artery disease where overlapped DCB are utilized for the treatment of the lesion, this will be considered as a single lesion. In case of a successful predilatation (i.e. no major (type D, E, F) angiographic dissections, residual stenosis ≤ 30% and TIMI flow = 3), the subject will be randomized in a 1:1 fashion to SelutionTM or SeQuent Please NeoTM. Randomization will be stratified according to DCB length (< 30 mm or ≥ 30 mm) in order to include at least 100 patients treated with DCB of 30 mm or longer. Measurements of intramyocardial resistances, after lesion preparation prior to DCB treatment and after DCB treatment (2 measurements), will be limited to a maximum of 100 lesions treated with DCB ≥ 30 mm. Given the lack of literature data on intramyocardial resistance measurements, a minimum of 100 subjects is considered necessary to provide an initial evaluation of these parameters. With a total sample size of 140 patients for the study, it will be allowed to enroll up to 40 patients treated with DCB < 30 mm. Once this limit is reached, only patients treated with DCB ≥ 30 mm will be enrolled while maintaining a 1:1 randomization ratio. During the index procedure, it is possible to treat other not study lesions (if applicable) with any other commercial device (e.g. drug-eluting stent) if they are located in a different epicardial territory than the study target lesion. All not studylesions should be treated prior to study target lesion procedure, and should be successful and uncomplicated.
Follow-up by phone call will occur at 1 and 6 months post-PCI. At 12 months all subjects will perform an angiographic follow up at the same site where the index procedure was performed. Quantitative Coronary Angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and on follow up angiography by the imaging core lab. FFR assessment will be performed at the time of follow-up angiography.
All subjects must receive dual anti-platelet therapy (DAPT), being aspirin (ASA) and P2Y12 inhibition therapy for at least 1 month after drug coated balloon PCI or according to standard local practice (with the choice of agent left to the discretion of the investigator), followed by ASA monotherapy indefinitely. However, in case the subject had recent ACS or is receiving additional drug-eluting stents, DAPT must be given according to local standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 140 subjects will be enrolled in a competitive way and 1:1 randomized to receive treatment with either the study device (SelutionTM) or the control device (SeQuent Please NeoTM). Randomization will be stratified according to DCB length: at least 100 patients treated with DCB ≥ 30 mm will be assigned to either SelutionTM or SeQuent Please NeoTM, while a maximum of 40 patients treated with DCB < 30 mm will be assigned to either SelutionTM or SeQuent Please NeoTM. A minimum of 100 subjects treated with DCB ≥ 30 mm is considered necessary to provide an initial evaluation of intramyocardial resistance measurements, due to the lack of literature data on these parameters.
| Arm | Type | Receives |
|---|---|---|
| sirolimus-eluting balloon (Selution) | Experimental | Device: sirolimus-eluting balloon (Selution)DCB angioplasty with a sirolimus-eluting balloon |
| paclitaxel-eluting balloon (SeQuent Please Neo) | Active comparator | Device: paclitaxel-eluting balloon (SeQuent Please Neo)DCB angioplasty with a paclitaxel-eluting balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects ≥18 years
- Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values.
- The subject has at least one de-novo lesion in a small vessel (>2.00 mm and ≤3.00 mm prior to pre-dilatation) with a diameter stenosis between 50% and 99% (prior to pre-dilatation). It is possible to enroll subjects that have a stent previously implanted in the same epicardial territory (main vessel and ramifications) of the target lesion
- Patients with target lesion to be treated with DCB < 30 mm in length (up to 40 patients) or with DCB ≥ 30 mm in length (at least 100 patients)
- Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up
Key exclusion criteria (24 listed)
- Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
- Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
- Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor
- Subjects who experienced a previous PCI with DCB in the epicardial territory (main vessel and ramifications) where the target lesion is located, during the last 12 months
- Subject suffered from stroke/TIA during the last 6 months
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 |
|---|---|---|
| sirolimus-eluting balloon (Selution)PCI treatment with DCB, in particular sirolimus coated balloon | Device | sirolimus-eluting balloon (Selution) |
| paclitaxel-eluting balloon (SeQuent Please Neo)PCI treatment with DCB, in particular paclitaxel coated balloon | Device | paclitaxel-eluting balloon (SeQuent Please Neo) |
Primary outcome
In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure
Time frame: 12 months post-procedure
The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure. Net Gain is defined as acute gain at the time of the index procedure minus late loss at the time of follow-up angiography.
Fractional Flow Reserve (FFR)
Time frame: From enrollment to the end of treatment at 12 months
FFR (absolute value) at 12 months post-procedure
13 secondary outcomes
Device success (lesion based)
Time frame: 12 months post-procedure
Procedure success
Time frame: 12 months post-procedure
Angiographic outcomes 1
Time frame: 12 months post-procedure
Angiographic outcomes 2
Time frame: 12 months post-procedure
Angiographic outcomes 3
Time frame: 12 months post-procedure
Angiographic outcomes 4
Time frame: 12 months post-procedure
Device oriented Composite Endpoint (DoCE/ TLF)
Time frame: 12 months post-procedure
Acute/subacute/early/late vessel thrombosis
Time frame: 12 months post-procedure
Periprocedural myocardial infarction
Time frame: From enrollment to the end of treatment at 12 months
PCI related myocardial injury
Time frame: From enrollment to the end of treatment at 12 months
Absolute difference in CFR for the first 100 patients treated with DCB ≥ 30 mm
Time frame: baseline
Absolute variation in IMR for the first 100 patients treated with DCB ≥ 30 mm
Time frame: baseline
Absolute decrease in CFR for the first 100 patients treated with DCB ≥ 30 mm
Time frame: baseline
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 3 Dec 2025.
- Background: PubMed 35685283Duan Y, Wang Y, Zhang M, Li Z, Chen L, Miao H, Pei S, Lu Y, Wang Z. Computational Pressure-Fluid Dynamics Applied to Index of Microcirculatory Resistance, Predicting the Prognosis of Drug-Coated Balloons Compared With Drug-Eluting Stents in STEMI Patients. Front Physiol. 2022 May 24;13:898659. doi: 10.3389/fphys.2022.898659. eCollection 2022.
- Background: PubMed 31525096Nishi T, Murai T, Ciccarelli G, Shah SV, Kobayashi Y, Derimay F, Waseda K, Moonen A, Hoshino M, Hirohata A, Yong ASC, Ng MKC, Amano T, Barbato E, Kakuta T, Fearon WF. Prognostic Value of Coronary Microvascular Function Measured Immediately After Percutaneous Coronary Intervention in Stable Coronary Artery Disease: An International Multicenter Study. Circ Cardiovasc Interv. 2019 Sep;12(9):e007889. doi: 10.1161/CIRCINTERVENTIONS.119.007889. Epub 2019 Sep 6.
- Background: PubMed 12821539Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23.
- Background: PubMed 34556322Del Buono MG, Montone RA, Camilli M, Carbone S, Narula J, Lavie CJ, Niccoli G, Crea F. Coronary Microvascular Dysfunction Across the Spectrum of Cardiovascular Diseases: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Sep 28;78(13):1352-1371. doi: 10.1016/j.jacc.2021.07.042.
- Background: PubMed 28134126Colleran R, Harada Y, Kufner S, Giacoppo D, Joner M, Cassese S, Ibrahim T, Laugwitz KL, Kastrati A, Byrne RA. Changes in high-sensitivity troponin after drug-coated balloon angioplasty for drug-eluting stent restenosis. EuroIntervention. 2017 Oct 20;13(8):962-969. doi: 10.4244/EIJ-D-16-00939.
- Background: PubMed 25819189Ikenaga H, Kurisu S, Ishibashi K, Dohi Y, Fukuda Y, Kihara Y. Slow-flow phenomenon after Paclitaxel-coated balloon angioplasty: findings from optical coherence tomography and coronary angioscopy. JACC Cardiovasc Interv. 2015 Apr 20;8(4):e59-62. doi: 10.1016/j.jcin.2014.11.016. Epub 2015 Mar 26. No abstract available.
- Background: PubMed 23361864Young M, Cuculi F, Erne P. PTCA with drug-coated balloons is associated with immediate decrease of coronary flow reserve. Catheter Cardiovasc Interv. 2013 Mar;81(4):682-6. doi: 10.1002/ccd.23502. Epub 2013 Jan 29.
- Background: PubMed 38506736Aihara K, Torii S, Ito M, Koseki K, Shiozaki M, Sato Y, Nakamura N, Yoshikawa A, Ikari Y, Nakazawa G. Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model. EuroIntervention. 2024 Mar 18;20(6):e389-e398. doi: 10.4244/EIJ-D-23-00425.
- Background: PubMed 39070273Kawai K, Rahman MT, Nowicki R, Kolodgie FD, Sakamoto A, Kawakami R, Konishi T, Virmani R, Labhasetwar V, Finn AV. Efficacy and Safety of Dual Paclitaxel and Sirolimus Nanoparticle-Coated Balloon. JACC Basic Transl Sci. 2024 May 1;9(6):774-789. doi: 10.1016/j.jacbts.2024.02.002. eCollection 2024 Jun.
- Background: PubMed 30871939Boitet A, Grassin-Delyle S, Louedec L, Dupont S, Lamy E, Coggia M, Michel JB, Coscas R. An Experimental Study of Paclitaxel Embolisation During Drug Coated Balloon Angioplasty. Eur J Vasc Endovasc Surg. 2019 Apr;57(4):578-586. doi: 10.1016/j.ejvs.2018.11.019. Epub 2019 Mar 11.
- Background: PubMed 35780056Nakamura R, Torii S, Kato T, Kawasaki D. A Case of Vasculitis Due to Distal Particulate Embolization After Use of Drug-Coated Balloon. JACC Cardiovasc Interv. 2022 Jul 25;15(14):1486-1487. doi: 10.1016/j.jcin.2022.05.030. Epub 2022 Jun 29. No abstract available.
- Background: PubMed 29754850Torii S, Yahagi K, Mori H, Harari E, Romero ME, Kolodgie FD, Young B, Ragheb A, Virmani R, Finn AV. Biologic Drug Effect and Particulate Embolization of Drug-Eluting Stents versus Drug-Coated Balloons in Healthy Swine Femoropopliteal Arteries. J Vasc Interv Radiol. 2018 Jul;29(7):1041-1049.e3. doi: 10.1016/j.jvir.2018.02.006. Epub 2018 May 10.
- SELUTION SLR™ 014 In-stent RestenosisLink provided by the sponsor.
- Non-Inferiority Clinical TrialsLink provided by the sponsor.
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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.
Riccardo RF Falzone contact
Antonio AC Colombo, MD study chair
Fondazione Evidence ONLUS
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sirolimus-eluting balloon (Selution) and paclitaxel-eluting balloon (SeQuent Please Neo) in people with Coronary Artery Disease and Stenosis Coronary, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 10 sites in Italy.
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 6 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. 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?
Contact Marina MCS Cornacchia Schenetti (03761810406, schema1950@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure (time frame: 12 months post-procedure). 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 NCT06373601, which also lists 58 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 3 Dec 2025.