SPYRAL GEMINI Pilot Study
Zusammenfassung der Studie
The study investigates the treatment of uncontrolled hypertension (with and without high cardiovascular risk) using multi-organ denervation. The Gemini system includes the following products: • Symplicity G3 Generator • Gemini Study Generator • Symplicity Spyral Catheter The Gemini system is currently in the testing phase, as it is not CE marked and not approved for public use. In this trial, the denervation procedure is referred to as 'multi-organ denervation' (MOD) because it is performed at two body sites. The MOD procedure is conducted in target areas in the kidneys and the hepatic artery. The hepatic artery is a large blood vessel that supplies several organs (liver, pancreas, etc.) with blood. Patients will be assigned to one of 2 study groups. Patients will know which group they belong to. Some study visits and tests will differ for each group. Both groups will undergo the MOD procedure. • 'Off Med' Group – This group includes participants who do not have known high cardiovascular risk. If you are in this group, the investigator will create a plan for tapering your blood pressure medications before the MOD procedure is performed. • 'On Med' Group – This group includes participants with certain cardiovascular risk factors (type 2 diabetes and overweight). If you are in this group, you will not stop your blood pressure medications before the MOD procedure. Data/information will be collected for this study up to 36 months after the multi-organ denervation.
(BASEC)
Untersuchte Intervention
The purpose of the SPYRAL GEMINI pilot study is to investigate the safety of multi-organ denervation using the Gemini system and to provide evidence for blood pressure reduction in a population with uncontrolled hypertension, both with and without high cardiovascular risk.
The SPYRAL GEMINI pilot study will be conducted with two parallel single-arm cohorts:
Gemini Pilot Off Med: Cohort with MOD for hypertension without the administration of antihypertensive agents
• Prospective enrollment of up to 75 participants for treatment with multi-organ denervation (MOD)
Gemini Pilot On Med: Cohort with MOD for hypertension and high cardiovascular risk with the administration of antihypertensive agents
• Prospective enrollment of up to 100 participants for treatment with multi-organ denervation (MOD).
Up to 20 study centers will treat a total of up to 175 participants in the Gemini Pilot Off Med and Gemini Pilot On Med cohorts. All participants treated with renal and liver denervation will be followed for a period of 3 years after the procedure, and data will be collected from the participants.
The screening will include approximately 1225 potential participants from the USA, EU, and Australia, and up to 175 participants will be treated. This study does not have statistically significant endpoints. The sample size of up to 175 participants was selected to provide evidence for treatment effect and to lay the groundwork for the design of a future pivotal study.
Data will be collected from study patients at the following time points:
- Initial examination
- Visit for medication discontinuation (Off Med group)
- Enrollment in the study
- Multi-organ denervation
- Hospital discharge
- 1, 2 (Off Med group), 3, 4 (Off Med group), 6, 12, 24, 36 month(s) after denervation
(BASEC)
Untersuchte Krankheit(en)
We aim to investigate whether multi-organ denervation using the Gemini system is a safe and effective treatment for lowering blood pressure in patients with uncontrolled hypertension, both with and without high cardiovascular risk. The Gemini system is used for the treatment of uncontrolled hypertension through renal denervation and is approved for this purpose. In this trial, the Gemini system will be tested for the first time in humans in the liver denervation procedure. The same applies to indications or techniques that deviate from the approval. Denervation is a procedure that stops nerve activity at targeted sites. The nervous system plays a crucial role in regulating blood pressure. In patients with uncontrolled hypertension, the nervous system may be excessively active between the brain and certain organs. Excessive nervous system activity could impair the functioning of these organs. For example, the kidneys may release more hormones than normal, which can contribute to hypertension. Some people take medications for hypertension. However, medication alone may not be sufficient to control blood pressure. Previous research has shown that interrupting certain nerves can lower blood pressure in some cases. In this trial, the denervation procedure is referred to as 'multi-organ denervation' (MOD) because it is performed at two body sites. The MOD procedure is conducted in target areas in the kidneys and the hepatic artery. The hepatic artery is a large blood vessel that supplies several organs (liver, pancreas, etc.) with blood. Patients will be assigned to one of 2 study groups. Patients will know which group they belong to. Some study visits and tests will differ for each group. Both groups will undergo the MOD procedure. • 'Off Med' Group – This group includes participants who do not have known high cardiovascular risk. If you are in this group, the investigator will create a plan for tapering your blood pressure medications before the MOD procedure is performed. • 'On Med' Group – This group includes participants with certain cardiovascular risk factors (type 2 diabetes and overweight). If you are in this group, you will not stop your blood pressure medications before the MOD procedure. Data/information will be collected for this study up to 36 months after the multi-organ denervation.
(BASEC)
All participants (both cohorts): 1. Aged ≥18 to ≤80 years 2. Diagnosis of hypertension and systolic blood pressure (SBP) in the clinic of ≥150 mmHg to <180 mmHg, diastolic blood pressure (DBP) in the clinic of ≥90 mmHg 3. 24-hour average SBP ≥140 mmHg to <170 mmHg measured with the ABPM (ambulatory 24-hour blood pressure monitor) at the baseline visit. Additional inclusion criteria only for the Gemini Pilot Off Med cohort: 1. Currently being treated with antihypertensive agents and consenting to taper these by the follow-up visit 3 months after the procedure. Additional inclusion criteria only for the Gemini Pilot On Med cohort: 1. Type 2 diabetes mellitus with HbA1c ≥ 6.5 to ≤ 9.0 % within 3 months prior to the screening visit 2. The participant must have been treated with a stable dose of antidiabetic agents for at least 6 months and have a stable weight (+/- 5 %) for at least 6 months prior to the screening visit and until the baseline visit 3. The participant must have been treated with a stable dose of one, two, or three classes of antihypertensive medications for at least 4 weeks prior to the screening visit and until the baseline visit. Participants prescribed 3 classes of antihypertensive medications must also have been prescribed a diuretic 4. BMI ≥ 28 to ≤ 40 kg/m2 (BASEC)
Ausschlusskriterien
All participants (both cohorts): 1. Anatomical abnormalities of the renal artery OR common hepatic artery unsuitable for treatment 2. Previous renal or liver denervation 3. One or more of the following conditions: stable or unstable angina within 3 months prior to enrollment, myocardial infarction within 3 months prior to enrollment, any heart failure or atrial fibrillation in the medical history. Patients with atrial fibrillation treated with surgical or catheter ablation and who are in sinus rhythm are not excluded. Patients are allowed to take aspirin or clopidogrel to reduce cardiovascular risk. 4. Previous stroke or transient ischemic attack. 5. Documented type 1 diabetes or use of insulin or sulfonylureas within 6 months prior to the index procedure. 6. Secondary causes of hypertension 7. Documented condition that makes precise blood pressure measurements impossible using the methods specified in the protocol 8. Documented disruptive condition that, in the investigator's opinion, could affect the safety of the participant 9. Chronic need for oxygen supplementation or mechanical ventilation, aside from nighttime respiratory support due to sleep apnea 10. Renal function failure 11. Pregnancy, breastfeeding, or planned pregnancy within the study period 12. Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to consent 13. Night shift work 14. Current or chronic pancreatitis (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
Medtronic Schweiz
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. Lucas Lauder
+41 613283402
lucas.lauder@clutterusb.chUniversitätsspital Basel
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
11.08.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Global pilot study of rEnal and hepatic coMbINed denervatIon in subjects with Uncontrolled Hypertension with and without High Cardiovascular Risk (SPYRAL GEMINI Pilot Study) (BASEC)
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