Идёт набор NCT07013929

Spyral InSight Study

Без фазы С лечением Hypertension Vascular Diseases Cardiovascular Diseases

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: Renal nerve stimulation.
Кому может быть актуально: Состояния в реестре: Hypertension, Vascular Diseases, Cardiovascular Diseases. Базовые параметры: 20 лет — 70 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: Греция, Ирландия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Spyral InSight Early Clinical Feasibility Study

Обзор

The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.

Подробное описание

This study is exploratory in nature and an early-stage clinical assessment that will evaluate procedural and long-term safety of renal nerve stimulation (RNS) when performed prior to and post renal artery denervation (RDN) with the Symplicity Spyral system, with follow-up at 1, 3, 6 and 12 months.

There is no pre-specified primary endpoint. However, the objectives of the Spyral InSight ECF study are as follows:

* To assess safety of RNS when performed prior to and post RDN. * To characterize and quantify the physiological response to renal nerve stimulation in humans undergoing renal denervation per approved labeling.

Вмешательства

Устройство Renal nerve stimulation
Renal nerve stimulation will be performed prior to and post renal denervation.

Первичные конечные точки

All-cause mortality [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
End-stage renal disease [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
Myocardial infarction [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
Incidence of stroke [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
Hospitalization for hypertensive crisis not related to non-adherence with medications [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
Significant embolic event resulting in end-organ damage [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
Renal artery intervention [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
New renal artery stenosis >70%, confirmed by angiography and as determined by the angiographic core lab [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
Vascular complications [Срок оценки: Through study completion, from enrollment to 12-month follow-up]
Major bleeding according to TIMI definition [Срок оценки: Through study completion, from enrollment to 12-month follow-up]

Критерии участия

Критерии включения

20 - 70 years of age
Office SBP ≥150 mmHg and <180 mmHg and DBP ≥90 mmHg
Individual is prescribed with one, two, or three antihypertensive medication classes
24-hour ABPM average of SBP ≥135 and <170 mmHg at Baseline

Критерии исключения

Prior renal denervation.
Individual lacks appropriate renal artery Anatomy
Has a renal artery stent
Individual has an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2
Individual is taking SGLT2 inhibitors or GLP-1 agonists
Individual requires chronic oxygen support or mechanical ventilation
Primary pulmonary hypertension.
Secondary cause of hypertension
Pregnant, nursing or planning to become pregnant during the study.
Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
Individual is currently taking anti-mineralocorticoid drugs.

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

Здоровые добровольцы: Нет