Selution DeNovo Study: A randomized, multicenter, international, and open clinical trial comparing the Selution DEB strategy versus the DES strategy.
Descrizione riassuntiva dello studio
This is a randomized, multicenter, international, and open clinical trial. Randomized means that many studies compare two or more different types of treatments. For example, treatment with the device under investigation may be compared to treatment with already conventional devices. Two groups of participants must then be formed, one group receiving the device under investigation and another receiving the current standard of care devices (drug-eluting stents). The term "randomize" refers to determining randomly which group each participant will be in. Whether a given participant receives the device under investigation or the control device is therefore a matter of chance. An open trial is a type of clinical trial in which information is not hidden from participants. In particular, both the study doctors and the participants know which treatment is being administered. The study will take place in approximately 15 countries in Europe and Asia, with 50 participating sites, to include 3326 subjects. The objective of the study is to compare two treatment strategies for narrowed blood vessels in the heart. One of the strategies involves using the SELUTION SLR balloon and the other involves using any drug-eluting stent (DES). The sponsor, with this study, would like to demonstrate that the treatment strategy using the SELUTION SLR balloon yields similar (after one year) or even better (after five years) results compared to the DES strategy.
(BASEC)
Intervento studiato
The aim of the study is to compare two treatment strategies to open narrowed blood vessels in the heart. One strategy uses the SELUTION SLR ™ balloon and the other strategy uses any drug-eluting stent (DES).
(BASEC)
Malattie studiate
Subjects presenting with chronic coronary syndrome (CCS), unstable angina, or NSTEMI with an indication for PCI and planned intervention.
(BASEC)
1. Documented angina and/or positive functional test or unstable angina or presentation of a stabilized NSTEMI. 2. Life expectancy >1 year 3. One or more native target vessels (LAD, LCX, or RCA) considered to require intervention and suitable for treatment of all lesions with DEB + provisional stenting or with DES and identified as such. (BASEC)
Criteri di esclusione
- The subject is unable to fully comply with the study protocol. - Contraindications to dual antiplatelet therapy, sirolimus, or its analogs - Presentation of a STEMI (BASEC)
Luogo dello studio
Basilea, Berna, Friburgo, Ginevra, San Gallo, Zurigo
(BASEC)
Sponsor
M.A. Med Alliance SA, Nyon, Suisse
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Tamara Solaja
+31 643600231
selutiondenovo@cluttermedalliance.comM.A. Med Alliance SA, Nyon, Suisse
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
06.05.2021
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Selution DeNovo A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy. (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
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Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
non disponibile