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Recruiting NCT06907147

SPYRAL GEMINI Pilot Study

No phase Interventional Hypertension Vascular Diseases Cardiovascular Diseases Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-Organ Denervation Gemini System.
Who it may be relevant to
Registry conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Germany, Greece, Ireland +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk

Overview

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.

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).

Interventions

  • Device Multi-Organ Denervation Gemini System
    After angiography according to standard procedures, subjects are treated with renal denervation followed by hepatic denervation.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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.
  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Stanford Hospital and Clinics — Stanford
  • Orlando Health Heart & Vascular Institute — Orlando
  • BayCare Health System Mease Countryside Hospital — Safety Harbor
  • Piedmont Heart Institute — Atlanta
  • Beth Israel Deaconess Medical Center — Boston
  • Henry Ford Providence Hospital — Southfield
  • North Mississippi Medical Center — Tupelo
  • Renown Regional Medical Center — Reno
  • … and 4 more centers
Germany · 2 centers
  • University Hospital Erlangen — Erlangen
  • Universität des Saarlandes — Homburg
Australia · 1 center
  • Royal Perth Hospital (Dobney Hypertension Centre) — Perth
Greece · 1 center
  • Hippokration General Hospital — Athens
Ireland · 1 center
  • University Hospital of Galway — Galway
Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT06907147 · MDT23034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗