Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry (SELUTION)

Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety.

The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: SELUTION SLRTM sirolimus coated balloon

Detailed Description

Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR in all settings, in order to evaluate its effectiveness and safety.

The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.

• Study Type: Observational
• Enrollment (Estimated): 960

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 0034987876135; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: ORIOL RODRIGUEZ LEOR, MD, PhD; Phone Number: 0034934978989; Email: oriolrodriguez@gmail.com

Study Locations

• Spain
  • Badalona, Spain, 08916
    • Recruiting
    • Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau
  • San Cristóbal de La Laguna, Spain, 38320
    • Recruiting
    • Hospital Universitario de Canarias
  • Santander, Spain, 39008
    • Recruiting
    • Hospital Universitario Marques de Valdecilla
  • Terrassa, Spain, 08221
    • Recruiting
    • Hospital Universitari MútuaTerrassa
  • Torrevieja, Spain, 03186
    • Recruiting
    • Hospital Universitario de Torrevieja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients treated with the Selution SLRTM device

Description

Inclusion Criteria:

• Patients with age ≥18 years and;
• Patients with coronary artery disease in whom, at the operator's discretion, treatment of a lesion in a native vessel, coronary graft or coronary restenosis is decided using the Selution SLRTM device;
• Patient who has been informed of the characteristics of the study and has provided written informed consent.

Exclusion Criteria:

• Express refusal of the patient to participate in the study
• Life expectancy of the patient of less than 12 months

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease (CAD)	Device: SELUTION SLRTM sirolimus coated balloon; Patients in whom treatment with SELUTION SLRTM sirolimus coated balloon has been attempted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE (Major Adverse Cardiovascular Events)	Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization)	12 months
TLR	Number of Target Lesion Revascularizations	12 months
DoCE (Device-oriented Composite Endpoint)	Incidence of DoCE, defined as Cardiovascular death, device failure-related MI (Myocardial Infarction) or device failure-related ischaemia)	12 months
PoCE (Patient-oriented Composite Endpoint)	Incidence of PoCE defined as all cause death, any stroke, any MI or any revascularization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLR in ISR	Number of Target Lesion Revascularizations in patients with ISR (in-stent restenosis)	12 months
TLR in primary lesions in native vessel	Number of Target Lesion Revascularizations in primary lesions in native vessel	12 months
TLR in bifurcation side branch lesions	Number of Target Lesion Revascularizations in bifurcation side branch lesions	12 months
MACE (Major Adverse Cardiovascular Events) in ISR	Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) in ISR	12 months
MACE (Major Adverse Cardiovascular Events) in primary lesions in native vessel	Incidence of MACE defined as death, non fatal myocardial infarction, or need for TLR (Target Target Lesion Revascularization) in primary lesions in native vessel	12 months
MACE (Major Adverse Cardiovascular Events) in bifurcation side branch lesions	Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) in primary lesions in bifurcation side branch lesions	12 months
Procedure success	Device success defined as residual stenosis <30% by visual assessment and or online QCA (Quantitative Coronary Analysis) < 40%, absence of dissection and TIMI 3 flow	1 day
Death	Incidence of Death defined as all-cause, cardiac, device related, procedure related	12 months
Non fatal Myocardial Infarction	Incidence of Non fatal Myocardial Infarction	12 months

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
• Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29.
• Costa RA, Mandal SC, Hazra PK, Chopda M, Chandra P, Damiani LP, Abizaid A, Hiremath S. Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions. Cardiovasc Revasc Med. 2022 Dec;45:18-25. doi: 10.1016/j.carrev.2022.08.037. Epub 2022 Sep 5.
• Madanchi M, Cioffi GM, Attinger-Toller A, Seiler T, Somm S, Koch T, Tersalvi G, Wolfrum M, Moccetti F, Toggweiler S, Kobza R, Levine MB, Garcia-Garcia HM, Bossard M, Cuculi F. Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon. Cardiol J. 2022;29(6):906-916. doi: 10.5603/CJ.a2022.0106. Epub 2022 Nov 17.
• Spaulding 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: rEPIC16- SELUTION