Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease

Официальное название

ADVANCEd NanoTherapies SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis (ISR) and de Novo Lesions

Обзор

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.

Вмешательства

• Устройство SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
  SirPlux Duo PTCA is a Drug-Coated Balloon to treat de novo and In-Stent Restenosis lesions in patients with symptomatic stable angina, unstable angina or NSTEMI

Первичные конечные точки

• Target lesion failure rate (TLF) [Срок оценки: 12 Months]

Вторичные конечные точки (6)

• Performance - Device Sucess [Срок оценки: Peri-procedural]
• Performance - Lesion Success [Срок оценки: Peri-procedural]
• Performance - Procedural Success [Срок оценки: Peri-Procedural through 7 days post-Procedure]
• Late Lumen Loss [Срок оценки: 6 months post procedure]
• Safety [Срок оценки: 24 months post procedure]
• Safety [Срок оценки: 24 Months post-procedure]

Критерии участия

Критерии включения

• ≥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.

Note: participants with NSTEMI must have enzymes that are trending down or are within normal limits prior to enrollment.

• 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.
• Target lesion must have a stenosis ≥ 50% and < 100%.
• Target lesion must have a visually estimated reference vessel diameter of:

• ISR lesions: 2.0 to 4.0 mm in diameter (inclusive)
• de novo lesions: 2.0 to <3.0 mm in diameter
• ISR lesions only: target lesion must be within a previous BMS or DES that does not extend >5.0 mm beyond the proximal or distal edge.

Критерии исключения

• 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).
• Planned PCI of any vessel within 30 days post-procedure and/or planned PCI of the target vessel within 12 months post-procedure.
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months to procedure.
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Documented left ventricular ejection fraction (LVEF) <30% at the most recent evaluation, within the prior 3 months to procedure.
• Planned surgery that would cause interruption in recommended DAPT duration per current guidelines.
• Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS, or other coronary artery imaging procedures.
• The following criteria related to previous treatments applies based on the type of lesion treated. The participant is excluded in the following circumstances:

• ISR lesions: If single-layer ISR, any previous treatment of the target vessel for restenosis. If double- layer ISR, any treatment of the double-layer ISR.
• de novo lesions: any previous treatment of the target lesion.
• Planned PCI of three vessel disease during procedure.
• Planned treatment of more than one target vessel. Tandem lesions that can be treated by a single DCB are permissible.
• Target lesion requires treatment with atherectomy, laser, or thrombectomy procedure.
• Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate.
• Target vessel has evidence of thrombus.
• Target vessel is excessively tortuous, defined as more than one bend >90° to reach target lesion.
• Target lesion has any of following characteristics:

• Lesion location is unprotected in left main coronary artery, internal mammary artery, aorto-ostial, bypass grafts, ostial lesions or within 5 mm of the origin of the left anterior descending or left circumflex.
• Involves a side branch >2.0 mm in diameter.
• Is severely calcified.
• The following criteria based on number and type of lesions:

• ISR and de novo lesions: target lesion is in the same vessel with a de novo lesion requiring treatment.
• ISR lesions: planned treatment of a ≥3 layer ISR lesion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 3 центра

• Hospital Clínic de Barcelona — Barcelona
• Hospital Universitario Marques de Valdecilla — Santander
• Hospital Alvaro Cunqueiro — Vigo

Идентификаторы

NCT: NCT07368933 · ANT-00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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