SPYRAL GEMINI Pilot Study
Purpose
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.
Conditions
- Hypertension
- Vascular Diseases
- Cardiovascular Diseases
- Chronic Kidney Diseases
- Diabetes Mellitus
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts 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
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Two parallel single-arm assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Stanford 5398563, California 5332921 94305
Atlanta 4180439, Georgia 4197000 30309-1281
Southfield 5010636, Michigan 5001836 48075-4818
Tupelo 4448903, Mississippi 4436296 38801-4934
Reno 5511077, Nevada 5509151 89502
Camden 4501018, New Jersey 5101760 08103
Dallas 4684888, Texas 4736286 75226
More Details
- NCT ID
- NCT06907147
- Status
- Recruiting
- Sponsor
- Medtronic Vascular
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).