Actively Recruiting
ADVANCEd NanoTherapies SirPlux Duo22 Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis and de Novo Lesions
Led by Advanced NanoTherapies · Updated on 2026-01-27
30
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the SirPlux Duo PTCA, a dual API-coated balloon catheter device, to treat coronary artery disease in patients with symptomatic stable angina, unstable angina, or non-ST elevation myocardial infarction (NSTEMI). The study focuses on treating two types of coronary lesions: in-stent restenosis (ISR) lesions measuring 2.00 to 4.00 mm in diameter and de novo lesions smaller than 3.00 mm. The goal is to assess the safety and performance of this device for these specific coronary conditions. Participants who meet the study criteria will undergo a planned percutaneous coronary intervention (PCI) using the SirPlux Duo PTCA balloon catheter. Only one target lesion will be treated per participant, with specific size and stenosis requirements for the target lesion. The treatment involves delivering the drug-coated balloon to the affected coronary vessel to evaluate procedural success and device performance. During the study, participants will be closely monitored with follow-up visits to assess outcomes such as target lesion failure rate at 12 months, procedural success, lesion success, late lumen loss at 6 months, and safety measures up to 24 months after the procedure. The study will involve various evaluations, including functional tests and clinical assessments, to track the device's performance and participant health throughout the follow-up period.
CONDITIONS
Brief 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 minimum legal age as required by local regulations
- Documented stable or unstable angina, positive functional test, or non-ST elevation myocardial infarction attributable to coronary vessel disease or in-stent restenosis
- Life expectancy greater than 1 year as judged by the investigator
- Willing and able to comply with study procedures and follow-up
- Treatment of only one target lesion, with specific size and stenosis requirements
- Target lesion length less than or equal to 36 mm
- Target lesion stenosis between 50% and less than 100%
- Target lesion 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, or positive pregnancy test within 7 days before procedure
- Known hypersensitivity or contraindication to antiplatelet medications or contrast media
- Allergic reaction to paclitaxel, sirolimus, or related derivatives
- Platelet count less than 100,000 or greater than 700,000 cells/mm3, or white blood cell count less than 3,000 cells/mm3 within 7 days before procedure
- Renal insufficiency with serum creatinine over 2.5 mg/dl or dialysis dependency
- Acute myocardial infarction within 72 hours of procedure (except NSTEMI with enzymes trending down or normal)
- Previous PCI of target vessel within 6 months
- Stroke or transient ischemic attack within 3 months prior to procedure if prasugrel is used
- Planned PCI of any vessel within 30 days post-procedure or target vessel within 12 months post-procedure
- Active peptic ulcer or recent upper gastrointestinal bleeding
- History of bleeding disorders or refusal of blood transfusions
- Left ventricular ejection fraction less than 30% within 3 months prior to procedure
- Planned surgery interrupting dual antiplatelet therapy
- Participation in another investigational drug or device study interfering with endpoints
- Previous treatments of target lesion or vessel as specified for lesion types
- Planned PCI of three-vessel disease or more than one target vessel
- Lesions requiring atherectomy, laser, or thrombectomy
- Target vessel with lesions over 50% stenosis or evidence of thrombus
- Excessively tortuous vessels with more than one bend over 90 degrees
- Lesion locations including unprotected left main coronary artery, internal mammary artery, aorto-ostial, bypass grafts, or ostial lesions
- Lesions involving large side branches, severe calcification, or multiple lesion types as specified
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo treatment with the SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to treat coronary artery lesions.
1 procedure visit (in-person)
Duration - Up to 24 months post-procedure
Participants are monitored for safety and treatment outcomes after the procedure.
Approximately 6 follow-up visits over 24 months
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
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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