Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Feasibility Study)
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
This is a prospective, single-arm, single-center initial feasibility 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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Asunción, Paraguay
- Cirugía Cardiovascular, Sanatorio Italiano
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Az eszköz megvalósíthatósága
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Procedure Success
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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MACE
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi igazgató: Randy E David, PhD, Advanced Bifurcation Systems Inc.
- Tanulmányi szék: Mehran Khorsandi, MD, Advanced Bifurcation Systems Inc.
- Kutatásvezető: Adrian Ebner, MD, Sanatorio Italiano, Asunción, Paraguay
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 082825
Terv az egyéni résztvevői adatokhoz (IPD)
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