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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06907147




Registration number
NCT06907147
Ethics application status
Date submitted
10/03/2025
Date registered
2/04/2025
Date last updated
15/07/2025

Titles & IDs
Public title
SPYRAL GEMINI Pilot Study
Scientific title
Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk
Secondary ID [1] 0 0
MDT23034
Universal Trial Number (UTN)
Trial acronym
SPYRAL GEMINI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Vascular Diseases 0 0
Cardiovascular Diseases 0 0
Chronic Kidney Diseases 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Multi-Organ Denervation Gemini System

Experimental: Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds -

Experimental: Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds. -


Treatment: Devices: Multi-Organ Denervation Gemini System
After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in office blood pressure
Timepoint [1] 0 0
From baseline to 36 months post-procedure

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/12/2029
Actual
Sample size
Target
175
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Perth Hospital (Dobney Hypertension Centre) - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Mississippi
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Greece
State/province [7] 0 0
Athens

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cecile Mahoney
Address 0 0
Country 0 0
Phone 0 0
+17635051057
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is not a plan to make IPD available.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06907147