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SPYRAL GEMINI Pilot Study

NCT06907147 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

DEVICE

Multi-Organ Denervation Gemini System

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

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2029-12-22
Completion
2029-12-22
FDA Device
Yes

Countries

  • United States
  • Australia
  • Germany
  • Greece
  • Ireland
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907147 on ClinicalTrials.gov