Recruiting

Gemini System

Sponsor:

Medtronic Vascular

Code:

NCT06907147

Conditions

Hypertension

Vascular Diseases

Cardiovascular Diseases

Chronic Kidney Diseases

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Multi-Organ Denervation Gemini System

Study Details

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

Study ID

NCT06907147

Start date

May 1, 2025

Status verified date

Jun, 2026

Completion date

Dec 22, 2029

Anticipated

Primary completion date

Dec 22, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

175 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Multi-Organ Denervation Gemini System

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

Primary outcome measure

  • Change in office blood pressure [ Time Frame: From baseline to 36 months post-procedure ]

Central Contacts and Locations

Central contacts

Locations

Stanford Hospital and Clinics

Recruiting

Stanford, California, United States, 94305

Contacts

Principal Investigator:

David Patrick Lee, MD

Orlando Health Heart & Vascular Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Principal Investigator:

Farhan J. Khawaja, MD

BayCare Health System Mease Countryside Hospital

Recruiting

Safety Harbor, Florida, United States, 34695

Contacts

Principal Investigator:

Parag Patel, MD

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309-1281

Contacts

Principal Investigator:

David Kandzari, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Eric Secemsky, MD

Henry Ford Providence Hospital

Recruiting

Southfield, Michigan, United States, 48075-4818

Contacts

Principal Investigator:

David Shukri, MD

North Mississippi Medical Center

Recruiting

Tupelo, Mississippi, United States, 38801-4934

Contacts

Principal Investigator:

Barry Bertolet, MD

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Kristen Gurnea, MPH

kristen.gurnea@renown.org

Lisa English, BS

lisa.english@renown.org

Principal Investigator:

Michael Bloch, MD

Virtua Our Lady of Lourdes Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Principal Investigator:

Kintur Sanghvi, MD

University of North Carolina (UNC) Memorial Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

George Stouffer, MD

Baylor Heart & Vascular Hospital

Recruiting

Dallas, Texas, United States, 75226

Contacts

Principal Investigator:

Cara East, MD

UT Health East Texas

Recruiting

Tyler, Texas, United States, 75701

Contacts

Elizabeth Seal, BSc, CCRC

903-510-7291elizabeth.seal@uthet.com

Principal Investigator:

Frank Navetta, MD

More Information

Sponsor

Medtronic Vascular

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Renal Insufficiency
  • Chronic Disease
  • Disease Attributes
  • Pathologic Processes
  • Kidney Diseases
  • Hypertension
  • Cardiovascular Diseases
  • Vascular Diseases
  • Denervation
  • Renal Denervation
  • Hepatic Denervation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medtronic Vascular on 2026-06-24.