Actively Recruiting
Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease
Led by Advanced NanoTherapies · Updated on 2026-01-27
30
Participants Needed
3
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older or minimum legal age as required by local regulations
- Documented stable or unstable angina, positive functional test, or non-ST elevation myocardial infarction attributed to coronary vessel or in-stent restenosis
- Participants with NSTEMI must have enzymes trending down or within normal limits before enrollment
- Life expectancy greater than 1 year
- Willing and able to cooperate with study procedures and follow-up evaluations
- Treatment required for only one target lesion (tandem lesions treated by a single DCB count as one lesion)
- Up to one de novo lesion in a separate vessel may be treated per standard care
- Target lesion length 36 mm or less
- Target lesion stenosis 50% or greater but less than 100%
- Target lesion reference vessel diameter: 2.0 to 4.0 mm for ISR lesions; 2.0 to less than 3.0 mm for de novo lesions
- ISR lesions must be within a previous BMS or DES not extending more than 5.0 mm beyond lesion edges
You will not qualify if you...
- Pregnant or breastfeeding; participants of childbearing potential must have negative pregnancy test within 7 days before procedure
- Known hypersensitivity or contraindication to antiplatelet medications or contrast media that cannot be pre-medicated
- History of allergic reaction or sensitivity to paclitaxel, sirolimus, or related drugs
- Platelet count less than 100,000 cells/mm³ or greater than 700,000 cells/mm³, or white blood cell count less than 3,000 cells/mm³ within 7 days prior to procedure
- Renal insufficiency with serum creatinine over 2.5 mg/dl within 7 days prior or dialysis dependent
- Acute myocardial infarction within 72 hours of procedure (NSTEMI allowed if enzymes trending down or normal)
- Previous PCI of target vessel within 6 months prior to procedure
- Stroke or transient ischemic attack within 3 months prior to procedure (any prior stroke or TIA if prasugrel used)
- Planned PCI of any vessel within 30 days post-procedure or target vessel within 12 months post-procedure
- Active peptic ulcer or upper GI bleeding within 6 months prior
- History of bleeding disorders or refusal of blood transfusions
- Left ventricular ejection fraction less than 30% within 3 months prior
- Planned surgery that interrupts recommended dual antiplatelet therapy
- Participation in another investigational drug or device study interfering with current study
- For ISR lesions: previous treatment of single-layer ISR target vessel or any treatment of double-layer ISR
- For de novo lesions: any previous treatment of target lesion
- Planned PCI of three vessel disease during procedure
- Planned treatment of more than one target vessel except tandem lesions treated by single DCB
- Target lesion requires atherectomy, laser, or thrombectomy
- Target vessel has other lesions with over 50% stenosis
- Target vessel has thrombus
- Target vessel is excessively tortuous with more than one bend over 90 degrees
- Target lesion in unprotected left main coronary artery, internal mammary artery, aorto-ostial, bypass grafts, ostial lesions, or within 5 mm of origin of left anterior descending or left circumflex
- Target lesion involves a side branch over 2.0 mm
- Target lesion is severely calcified
- Target lesion is in same vessel with de novo lesion requiring treatment
- Planned treatment of three or more layer ISR lesion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
2
Hospital Universitario Marques de Valdecilla
Santander, Spain
Actively Recruiting
3
Hospital Alvaro Cunqueiro
Vigo, Spain
Actively Recruiting
Research Team
M
Marwan Berrada-Sounni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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