Selution DeNovo Study: A randomized, multicenter, international, and open clinical trial comparing the Selution DEB strategy versus the DES strategy.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- 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)
Lieu de l’étude
Bâle, Berne, Fribourg, Genève, St-Gall, Zurich
(BASEC)
Sponsor
M.A. Med Alliance SA, Nyon, Suisse
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Tamara Solaja
+31 643600231
selutiondenovo@cluttermedalliance.comM.A. Med Alliance SA, Nyon, Suisse
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
06.05.2021
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Selution DeNovo A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy. (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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