Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus, Hypertension, Vascular Diseases
Conditions
Keywords
Renal Insufficiency, Chronic Disease, Disease Attributes, Pathologic Processes, Kidney Diseases, Hypertension, Cardiovascular Diseases, Vascular Diseases, Denervation, Renal Denervation, Hepatic Denervation
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).
Interventions
DEVICEMulti-Organ Denervation Gemini System
After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.
Sponsors
Medtronic Vascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two parallel single-arm assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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. History of NYHA Class III or IV heart failure within 6 months of screening visit. 4. Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability. 5. Documented Type 1 diabetes or use of insulin within 6 months. 6. Secondary cause of hypertension. 7. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement. 8. Estimated glomerular filtration rate (eGFR) of \<40 9. Pregnant, nursing or planning to become pregnant during the study. 10. Primary pulmonary arterial hypertension. 11. History or evidence of active / suspected chronic liver or biliary disease. 12. Current or chronic pancreatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in office blood pressure | From baseline to 36 months post-procedure |
Countries
Australia, Germany, Greece, Ireland, Switzerland, United States
Contacts
CONTACTCecile Mahoney
Outcome results
None listed