RecruitingCoronary Artery Disease

SELUTION 4 De Novo Small Vessel IDE Trial

Eligible age

18+ yrs

Accepts

All genders

Locations

32 states

Healthy volunteers

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About this study

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.

Sponsor: M.A. Med Alliance S.A.

You may qualify if…

✓ Clinical Inclusion Criteria
✓ Subjects must meet all of the following clinical criteria to participate in the trial:
✓ 1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
✓ 2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
✓ 3. 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.
✓ 4. Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).
✓ 5. Subject has life expectancy \> 1 year in the opinion of the investigator.
✓ 6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.

You may not qualify if…

✕ Clinical Exclusion Criteria
✕ Subjects who meet any of the following clinical criteria will be excluded from the trial:
✕ 1. Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
✕ 2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
✕ 3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
✕ 4. Subject with planned major surgery within 30 days following the index procedure.
✕ 5. Subject with planned treatment of lesion involving aorto-ostial location.
✕ 6. Subject with PCI of a non-target vessel within ± 30 days of the index procedure.