NCT07256249

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
960

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Dec 2025Jan 2027

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

November 20, 2025

Last Update Submit

March 20, 2026

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (9)

  • TLR in ISR

    12 months

  • TLR in primary lesions in native vessel

    12 months

  • TLR in bifurcation side branch lesions

    12 months

  • MACE (Major Adverse Cardiovascular Events) in ISR

    12 months

  • MACE (Major Adverse Cardiovascular Events) in primary lesions in native vessel

    12 months

  • +4 more secondary outcomes

Study Arms (1)

Coronary Artery Disease (CAD)

Device: SELUTION SLRTM sirolimus coated balloon

Interventions

SELUTION SLRTM sirolimus coated balloonDEVICE

Patients in whom treatment with SELUTION SLRTM sirolimus coated balloon has been attempted

Coronary Artery Disease (CAD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients treated with the Selution SLRTM device

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

RECRUITING

Hospital Universitari MútuaTerrassa

Terrassa, 08221, Spain

RECRUITING

Hospital Universitario de Torrevieja

Torrevieja, 03186, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22386286BACKGROUND

  • 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.

    PMID: 30170854BACKGROUND

  • 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.

    PMID: 36192319BACKGROUND

  • 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.

    PMID: 36385601BACKGROUND

  • 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.

    PMID: 36642225BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

ORIOL RODRIGUEZ LEOR, MD, PhD

CONTACT

0034934978989oriolrodriguez@gmail.com

FUNDACION EPIC

CONTACT

0034987876135iepic@fundacionepic.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

December 11, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

ES(5)