Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic… (NCT07368933) | Clinical Trial Compass
RecruitingNot Applicable
Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease
Spain30 participantsStarted 2025-12-15
Plain-language summary
The study objectives are:
1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease.
2. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions \<3.00 mm in diameter in patients with symptomatic coronary artery disease.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥18 years or minimum legal age as required by local regulations.
✓. Documented stable or unstable angina, positive functional test, or non -ST elevation myocardial infarction which, in the judgment of the operator, is attributable to disease in coronary vessel or in-stent restenosis, and the patient is deemed an appropriate candidate for PCI in accordance with the applicable guidelines on percutaneous coronary intervention.
✓. Life expectancy \>1 year in the Investigator's opinion.
✓. Participant is willing and able to cooperate with study procedures and follow-up evaluations.
✓. Treatment of only one target lesion required
✓. Tandem lesions treated by a single DCB will be considered one target lesion.
✓. Up to one de novo lesion in a separate vessel may be treated per standard of care at the procedure. Non-target lesions must be successfully treated under the same criteria of the target lesion, before treating the target lesion.
✓. Target lesion must be ≤36 mm in length.
Exclusion criteria
✕. Participant is pregnant, or breastfeeding. Note: Participant of childbearing potential must have a negative pregnancy test within 7 days before procedure.
✕. Known hypersensitivity or contraindication to antiplatelet medications (e.g., aspirin; heparin; prasugrel); or a sensitivity to contrast media which cannot be adequately pre-medicated.
. History of an allergic reaction or significant sensitivity to paclitaxel, sirolimus, or any other analogue or derivative.
✕. Platelet count \< 100,000 cells/mm³ (i.e., 100 x 109 /L) or \> 700,000 cells/mm³ (i.e., 700 x 10 9 /L), or a white blood cell (WBC) count \< 3,000 cells/mm³ within 7 days prior to procedure.
✕. Renal insufficiency (Serum creatinine level \> 2.5 mg/dl (i.e., 221 μmol/L) within 7 days prior to procedure) or failure (dialysis dependent).
✕. Evidence of an acute MI within 72 hours of the procedure Note: participants with NSTEMI are allowed, provided enzymes are trending down or are within normal limits prior to enrollment.
✕. Previous PCI of the target vessel within 6 months prior to procedure.
✕. History of a stroke or transient ischemic attack (TIA) within the prior 3 months to procedure (any prior stroke or TIA, if prasugrel is used).