Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Shockwave M5 IVL Catheter, Modified Seldinger Technique, Modified Seldinger Technique.
- Кому может быть актуально
- Состояния в реестре: Aortic Stenosis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
Подробное описание
This is a prospective randomized/control trial pilot study to compare clinical outcomes of common femoral artery access in patients undergoing TAVR at the University of Tennessee Medical. Specifically, This study compares patients utilizing the Shockwave model (M5) Intravascular Lithotripsy (IVL) prior to standard arterial access using the modified Seldinger technique to those utilizing the standard femoral artery access via the modified Seldinger approach without the utilization of intravascular lithotripsy in heavily calcified femoral arteries.
The secondary purposes of this study are to:
1. Determine the clinical outcomes between groups 2. Distinguish extravasation post closure at the end of the procedure 3. Compare the need for open vascular surgery between groups 4. Examine PTA or Stents to the CFA to help hemostasis or local vascular complications between groups 5. Number of Perclose devices used between groups 6. Compare Bleeding/Hematoma between groups 7. Examine the difference in hospital length of stay between groups 8. Examine renal function post procedure 9. Difference in pain or numbness in the distal extremity between groups 10. Mortality related to complications from vascular closure site between groups 11. Conversion to general anesthesia due to additional procedures required to address the CFA access site complications between groups
Вмешательства
- Устройство Shockwave M5 IVL Catheter
The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access - Процедура Modified Seldinger Technique
Standard of care for femoral access in patients with calcified femoral arteries - Процедура Modified Seldinger Technique
Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.
Первичные конечные точки
- Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure [Срок оценки: Immediately post-procedure]
Вторичные конечные точки (12)
- Determine need for Vascular surgery consultation [Срок оценки: During hospital stay (Day 0-3)]
- If vascular complication, was PTA, stenting, or open surgery used [Срок оценки: During hospital stay (Day 0-3)]
- Number of perclose devices used to close the femoral artery access site [Срок оценки: During procedure (Day 0)]
- Determine presence of other vascular complications I.e. bleeding, hematoma, emboli etc [Срок оценки: Within 3 days post-procedure]
- Change in Hemoglobin [Срок оценки: Day 0 to Day 3 post-procedure]
- Change in Serum Creatinine [Срок оценки: Day 0 to Day 3 post procedure]
- Incidence of Hypotension or Shock [Срок оценки: Day 0 to Day 3 post-procedure]
- Incidence of Infections or Sepsis [Срок оценки: Day 0 to Day 3 post-procedure]
- Determine if there is a difference between hospital length of stay [Срок оценки: From date of admission to date of discharge, assessed up to 60 days]
- Assess for difference in pain/numbness in distal extremities post-procedure (Yes/No) [Срок оценки: Within 3 days post-procedure]
- Assess for differences in mortality related to complications between the groups [Срок оценки: Up to 3 months post-procedure]
- Failure of treatment [Срок оценки: Day 0 to discharge (or up to 3 days post-procedure)]
Критерии участия
Критерии включения
- >18 years of age
- Patient with a diagnosis of severe aortic stenosis undergoing TAVR
- Participants must be able to read and understand study procedures
- Willing to participate and sign an ICF
- Patients with > 90-degree arc of calcium at the large bore access site per CT documentation
Критерии исключения
- Unable to understand study procedures
- Unwilling to give consent
- Patients with cognitive impairments that can affect their ability to give consent
- Unfavorable calcium distribution of femoral artery
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of Tennessee Medical Center — Knoxville
Идентификаторы
NCT: NCT07205068 · 5319 · Institutional Review Board