SELUTION 4 De Novo Small Vessel IDE Trial
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.A. Med Alliance S.A.
About this trial
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.
The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.
Eligibility criteria
Qualifiers
Clinical Inclusion Criteria
Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
Subject presents with chronic coronary syndromes [CCS] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention.
Disqualifiers
Clinical Exclusion Criteria
Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
Trial design
Treatments tested in this trial
- PCI with SELUTION SLR DCB
- PCI with FDA approved "-limus" DES
Treatment groups
960 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov