Advanced NanoTherapies Dual-API DCB to Treat De-Novo Lesions in Patients With Symptomatic Coronar… (NCT05521542) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Advanced NanoTherapies Dual-API DCB to Treat De-Novo Lesions in Patients With Symptomatic Coronary Artery Disease
Australia, Dominican Republic, New Zealand28 participantsStarted 2023-01-30
Plain-language summary
This prospective, single-arm, multi-center, safety and feasibility first-in-human study will evaluate the safety and feasibility of the SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter to treat de-novo lesions between ≥2.0 and ≤4.0 mm in patients with symptomatic stable angina, unstable angina, and NSTEMI.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion criteria
✓. The subject is ≥18 years and \<90 years old.
✓. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.
✓. Subject has been diagnosed with a symptomatic stable angina, or acute coronary syndrome.
✓. Life expectancy \> 1 year.
✓. The subject is planned to undergo a percutaneous coronary intervention for a known lesion meeting the angiographic criteria set out below.
✓. Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure. Men with a female partner of childbearing potential must agree to use condoms plus an additional reliable contraceptive method within 12 months after the index procedure.
✓. The subject is able and willing to comply with all assessments in the study, including dual antiplatelet therapy (DAPT), ASA indefinitely, and P2Y12 inhibitor for a minimum of 6 months for stable angina subjects, and 12 months for unstable angina and NSTEMI subjects.
✓. The subject shall be under optimal medical therapy for ASCVD, which includes at a minimum high-intensity statin therapy. If statin intolerant, the subject should be treated with a PCSK9 inhibitor, ezetimibe or bempedoic acid.
Exclusion criteria
✕1. Successful pre-dilation with semi and/or non-compliant balloon of the target lesion(s) (defined as no major flow-limiting dissections (Grade C or higher) and \<30% residual stenosis of the target lesion by a visual estimate on angiography). Adjunctive pre-dilation therapies such as scoring balloon, cutting balloon, and IVL are allowed. Rotablator or similar rotational atherectomy devices are restricted per protocol.
✕. Subject has current problems with substance abuse.
✕. Subject has a planned procedure that may cause non-compliance with the protocol.
✕. Subject participates in another investigational drug or device clinical study that has not reached its primary endpoint.
✕. Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
✕. Chronic total occlusion (CTO) of the target lesion(s) or Thrombolysis In Myocardial Infarction (TIMI) flow \< 2.
✕. Subject requires treatment of a coronary lesion(s) involving a bifurcation with significant ostial / proximal disease within 5mm of a side-branch greater than 2.0mm.
✕. Target lesion(s) within native or synthetic vessel grafts.