SPYRAL GEMINI Pilot Study

Официальное название

Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk

Обзор

The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.

Подробное описание

This study is exploratory in nature and will evaluate procedural and long-term safety of multi-organ denervation (MDN) and provide preliminary efficacy data in two parallel single arm cohorts:

* Gemini Pilot Off Med: MDN for Hypertension Off Anti-hypertensive Meds and, * Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds

There is no pre-specified primary endpoint; however, the data will be used for hypothesis generation to be evaluated and confirmed in subsequent clinical investigation(s).

Вмешательства

• Устройство Multi-Organ Denervation Gemini System
  After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.

Первичные конечные точки

• Change in office blood pressure [Срок оценки: From baseline to 36 months post-procedure]

Критерии участия

Критерии включения

All Subjects (both cohorts):

• ≥18 and ≤80 years of age.
• Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and <180 mmHg and an office DBP ≥ 90 mmHg.
• 24-hour average SBP ≥140 mmHg and <170 mmHg measured by ABPM at Baseline.

Критерии исключения

• Individual lacks appropriate renal artery OR common hepatic artery anatomy.
• Prior renal or hepatic denervation.
• History of NYHA Class III or IV heart failure within 6 months of screening visit.
• Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
• Documented Type 1 diabetes or use of insulin within 6 months.
• Secondary cause of hypertension.
• Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
• Estimated glomerular filtration rate (eGFR) of <40
• Pregnant, nursing or planning to become pregnant during the study.
• Primary pulmonary arterial hypertension.
• History or evidence of active / suspected chronic liver or biliary disease.
• Current or chronic pancreatitis.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• Stanford Hospital and Clinics — Stanford
• Orlando Health Heart & Vascular Institute — Orlando
• BayCare Health System Mease Countryside Hospital — Safety Harbor
• Piedmont Heart Institute — Atlanta
• Beth Israel Deaconess Medical Center — Boston
• Henry Ford Providence Hospital — Southfield
• North Mississippi Medical Center — Tupelo
• Renown Regional Medical Center — Reno
• … и ещё 4 центра

Германия · 2 центра

• University Hospital Erlangen — Erlangen
• Universität des Saarlandes — Homburg

Австралия · 1 центр

• Royal Perth Hospital (Dobney Hypertension Centre) — Perth

Греция · 1 центр

• Hippokration General Hospital — Athens

Ирландия · 1 центр

• University Hospital of Galway — Galway

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT06907147 · MDT23034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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