Selution DeNovo Study: A randomized, multicenter, international, and open clinical trial comparing the Selution DEB strategy versus the DES strategy.
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Basel, Bern, Freiburg, Geneva, St. Gallen, Zurich
(BASEC)
Sponsor
M.A. Med Alliance SA, Nyon, Suisse
(BASEC)
Contact
Contact Person Switzerland
Tamara Solaja
+31 643600231
selutiondenovo@cluttermedalliance.comM.A. Med Alliance SA, Nyon, Suisse
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
06.05.2021
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Selution DeNovo A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy. (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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