Clinical trial NCT06907147: SPYRAL GEMINI Pilot Study
Official title: Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
Keywords: Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Kidney Diseases
Hypertension
Cardiovascular Diseases
Vascular Diseases
Denervation
Renal Denervation
Hepatic Denervation
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel single-arm assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

All Subjects (both cohorts):

1. ≥18 and ≤80 years of age.
2. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
3. 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.

Exclusion Criteria:

1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.
2. Prior renal or hepatic denervation.
3. Prior stroke or transient ischemic attack (TIA).
4. Documented Type 1 diabetes or use of insulin or sulfonylureas within 6 months.
5. Secondary cause of hypertension.
6. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
7. Estimated glomerular filtration rate (eGFR) of \<40
8. Pregnant, nursing or planning to become pregnant during the study.
9. Primary pulmonary arterial hypertension.
10. History or evidence of active / suspected chronic liver or biliary disease.
11. Current or chronic pancreatitis.

Primary outcomes:
measure: Change in office blood pressure
timeFrame: From baseline to 36 months post-procedure
Secondary outcomes:
Other outcomes:
measure: Change in 24-hour ambulatory blood pressure
timeFrame: From baseline to 3 and 6 months post-procedure
measure: Change in daytime blood pressure
timeFrame: From baseline to 3 and 6 months post-procedure
measure: Change in nighttime blood pressure
timeFrame: From baseline to 3 and 6 months post-procedure
measure: Change in office blood pressure
timeFrame: From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Change in home blood pressure (HBP)
timeFrame: From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Incidence of achieving target office systolic blood pressure (SBP<140 mmHg)
timeFrame: From baseline to 1, 3, 6, 12, 24 and 36 months post-procedure
measure: All-cause mortality
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Significant embolic event resulting in end-organ damage
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Vascular complications
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Hospitalization for hypertensive crisis not related to non-adherence with medications or the protocol
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Major bleeding requiring transfusion
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Hepatic Arterial Damage requiring intervention (i.e., perforation, dissection, occlusion, aneurysm)
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Hepatic artery thrombosis
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: New Hepatic Stenosis >70%, confirmed by angiography
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Aminotransferase Elevation(s) >3x the upper limit of normal
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Myocardial Infarction
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Stroke
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Renal artery re-intervention
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: New renal artery stenosis >70% confirmed by angiography
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: End Stage Renal Disease or dialysis
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Increase in serum creatinine >50% from Baseline
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
measure: Any of the following requiring intervention or hospitalization: Pancreatitis, Biliary stricture, New onset biliary dyskinesia, Acute cholecystitis, Sphincter of Oddi dysfunction
timeFrame: From pre-procedure to immediately after the procedure, 1, 3, 6, 12, 24 and 36 months post-procedure
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Southfield
country: United States
facility: Henry Ford Providence Hospital
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
Study officials:
References: