Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH EFS)
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Early Feasibility Study)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This is a prospective, single-arm, single-center initial (EFS) clinical study enrolling subjects with symptomatic ischemic heart disease due to a de novo coronary bifurcation lesion. The objective is to obtain initial insights into the clinical safety of the device-specific aspects of the procedure; whether the device can be successfully delivered and implanted; whether there are any operator technique challenges with device use; human factors; clinical safety of the device and whether the device performs in accordance with its intended purpose.
All enrolled subjects will be treated with the study device during the index procedure and followed after treatment to assess procedural success, clinical safety, and device performance. Follow-up is conducted through 3 years.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Asunción, Paraguay
- Cirugía Cardiovascular, Sanatorio Italiano
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Be 21 years of age or older. Have symptomatic ischemic heart disease or objective evidence of reduced blood flow to the heart.
Be eligible for PCI, also known as coronary stenting. Have a new coronary artery narrowing involving a branch point that meets the study's angiographic requirements.
Be willing and able to complete study follow-up. Be able to provide written informed consent. If able to become pregnant, have a negative pregnancy test before the procedure and agree not to become pregnant or breastfeed for 1 year.
Exclusion Criteria:
Are currently participating in another investigational drug or device study that could interfere with this study.
Had a coronary intervention within 30 days before the planned study procedure. Need a planned additional coronary procedure soon after the study procedure. Had a prior stent placed close to the target lesion. Have a target lesion that requires certain other treatment devices before stent placement, other than balloon angioplasty or intravascular lithotripsy.
Have a serious medical condition that could limit participation, follow-up, or interpretation of the study results.
Have a life expectancy of less than 3 years. Have a condition requiring chronic immunosuppressive therapy or have a severe autoimmune or immunosuppressive condition.
Have significantly reduced heart pumping function. Had a recent acute heart attack, unless certain laboratory values have returned to acceptable levels.
Had a stroke or transient ischemic attack within the past 6 months. Have certain abnormal blood test results, including low white blood cell count, low neutrophil count, low platelet count, or significantly reduced kidney function.
Have active stomach or intestinal bleeding, active peptic ulcer disease, a bleeding disorder, or cannot receive blood transfusions.
Have a known allergy or contraindication to required medications, contrast dye, or study device materials that cannot be adequately managed.
Are pregnant, breastfeeding, or planning to become pregnant within 1 year after the study procedure.
Have coronary anatomy that is not suitable for the study device, as determined during coronary angiography (This may include blood clot in the target lesion, severe vessel tortuosity, severe calcification, certain lesion locations, or other significant disease in the target vessel).
Are unable or unwilling, in the opinion of the study doctor, to comply with the study requirements.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Proveditelnost zařízení
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Patients with coronary bifurcation lesions
Patients undergoing PCI to treat a bifurcation lesion
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The MD-SBA DES System is a single use, minimally invasive combination product that consists of a cobalt chromium metal coronary stent, coated with sirolimus in a PEA/BHT matrix, on a rapid exchange (RX) delivery system.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Procedure Success
Časové okno: Periprocedural
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To determine whether the device can be successfully delivered and implanted, as measured by attainment of <30% final residual stenosis of the target lesion and no in-hospital major adverse cardiac events (MACE).
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Periprocedural
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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MACE
Časové okno: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Percentage of subjects with major adverse cardiac events, defined as cardiac death, myocardial infarction, emergency coronary artery bypass surgery, or clinically driven target lesion revascularization.
Components of MACE, including cardiac death and myocardial infarction, may also be summarized.
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30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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TVF
Časové okno: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Percentage of subjects with target vessel failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.
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30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Target Lesion Revascularization of the Side Branch
Časové okno: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Percentage of subjects requiring repeat treatment of the side branch by percutaneous or surgical methods.
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30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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Stent thrombosis
Časové okno: 6-months, 1-year, 2-years, and 3-years post index procedure
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Percentage of subjects with late stent thrombosis.
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6-months, 1-year, 2-years, and 3-years post index procedure
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Acute Success
Časové okno: Index procedure
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Percentage of subjects with successful device delivery and target lesion treatment, including final residual stenosis <30% and adequate side branch flow.
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Index procedure
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Side Branch Access
Časové okno: Index procedure
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Percentage of subjects with TIMI-3 flow in the side branch and/or need to re-cross the side branch after study device use.
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Index procedure
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Bleeding / Vascular Complications
Časové okno: Hospital discharge
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Percentage of subjects with bleeding or vascular complications.
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Hospital discharge
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Procedure Time
Časové okno: Index procedure
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Duration of the index procedure in minutes
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Index procedure
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Fluoroscopy Time
Časové okno: Index procedure
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Total fluoroscopy duration during index procedure in minutes
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Index procedure
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Contrast Volume
Časové okno: Index procedure
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Total volume of contrast media used during index procedure in milliliters
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Index procedure
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Randy E David, PhD, Advanced Bifurcation Systems Inc.
- Studijní židle: Mehran Khorsandi, MD, Advanced Bifurcation Systems Inc.
- Vrchní vyšetřovatel: Adrian Ebner, MD, Sanatorio Italiano, Asunción, Paraguay
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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