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 range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.