SPYRAL GEMINI Pilot Study

Medtronic

Status: Enrolling

Conditions: Chronic Kidney Diseases; Hypertension; Diabetes Mellitus; Cardiovascular Diseases; Vascular Diseases

Treatments: Device: Multi-Organ Denervation Gemini System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06907147

MDT23034

Details and patient eligibility

About

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.

Full 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).

Enrollment: 175 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

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

Experimental group

Treatment:

Device: Multi-Organ Denervation Gemini System

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

Experimental group

Treatment:

Device: Multi-Organ Denervation Gemini System