SPYRAL GEMINI Pilot Study

NCT06907147 | Recruiting DMC FDA Device

• 1 other identifier: MDT23034
• Study Type: interventional
• Target: 175
• Locations: 5 countries
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in office blood pressure

  From baseline to 36 months post-procedure

Other Outcomes (22)

• Change in 24-hour ambulatory blood pressure

  From baseline to 3 and 6 months post-procedure

• Change in daytime blood pressure

  From baseline to 3 and 6 months post-procedure

• Change in nighttime blood pressure

  From baseline to 3 and 6 months post-procedure

Study Arms (2)

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

EXPERIMENTAL

Device: Multi-Organ Denervation Gemini System

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

EXPERIMENTAL

Device: Multi-Organ Denervation Gemini System

Interventions

Multi-Organ Denervation Gemini System DEVICE

After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.

Gemini Pilot Off Med: Multi-Organ Denervation for Hypertension Off Anti-hypertensive Meds; Gemini Pilot On Med: MDN for Hypertension and High Cardiovascular Risk On Anti-hypertensive Meds.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Subjects (both cohorts):
• ≥18 and ≤80 years of age.
• Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
• hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.

You may not qualify if:

• Individual lacks appropriate renal artery OR common hepatic artery anatomy.
• Prior renal or hepatic denervation.
• History of NYHA Class III or IV heart failure within 6 months of screening visit.
• Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
• Documented Type 1 diabetes or use of insulin within 6 months.
• Secondary cause of hypertension.
• Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
• Estimated glomerular filtration rate (eGFR) of \<40
• Pregnant, nursing or planning to become pregnant during the study.
• Primary pulmonary arterial hypertension.
• History or evidence of active / suspected chronic liver or biliary disease.
• Current or chronic pancreatitis.

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (13)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309-1281, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Henry Ford Providence Hospital

Southfield, Michigan, 48075-4818, United States

RECRUITING

North Mississippi Medical Center

Tupelo, Mississippi, 38801-4934, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Virtua Our Lady of Lourdes Hospital

Camden, New Jersey, 08103, United States

RECRUITING

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

RECRUITING

UT Health East Texas

Tyler, Texas, 75701, United States

RECRUITING

Royal Perth Hospital (Dobney Hypertension Centre)

Perth, 6000, Australia

RECRUITING

Hippokration General Hospital

Athens, 11527, Greece

RECRUITING

University Hospital of Galway

Galway, H91 YR71, Ireland

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Cecile Mahoney

CONTACT

+17635051057; Cecile.C.Mahoney@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two parallel single-arm assignment

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 2, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 22, 2029
• Study Completion (Estimated): December 22, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); AU (1); CH (1); GR (1); US (9)