SPYRAL GEMINI Pilot Study

Part of paid clinical trials in Stanford, California.

Sponsor
Medtronic Vascular
Study ID
NCT06907147
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Chronic Kidney Diseases
  • Diabetes Mellitus
  • Hypertension
  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
May 2026
Primary completion
Dec 22, 2029
Completion
Dec 22, 2029

Study Design

Enrollment
175 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Stanford Hospital and ClinicsStanfordCalifornia94305
Maria Perlas
[email protected]
650-723-2094
Isabella Ko
[email protected]
650-497-2367
David Patrick Lee, MD (PRINCIPAL_INVESTIGATOR)
Orlando Health Heart & Vascular InstituteOrlandoFlorida32806
Farhan J. Khawaja, MD
[email protected]
321-841-6444
George Ngo, DNP, MBA, PMSM
[email protected]
321-843-9657
Farhan J. Khawaja, MD (PRINCIPAL_INVESTIGATOR)
BayCare Health System Mease Countryside HospitalSafety HarborFlorida34695
Kristy Roakes
[email protected]
727-724-8611
Edith Rowson
[email protected]
727-724-2032
Parag Patel, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Heart InstituteAtlantaGeorgia30309-1281
David Kandzari, MD
[email protected]
404-605-2800
Wendy Noland
[email protected]
404-605-3561
David Kandzari, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jenifer Kaufman, DNP
[email protected]
617-632-8956
Jacob Luetje
[email protected]
617-632-7484
Eric Secemsky, MD (PRINCIPAL_INVESTIGATOR)
Anna Krawisz, MD (SUB_INVESTIGATOR)
Henry Ford Providence HospitalSouthfieldMichigan48075-4818
Yulia Abidov
[email protected]
248-849-5328
David Shukri, MD (PRINCIPAL_INVESTIGATOR)
North Mississippi Medical CenterTupeloMississippi38801-4934
Brittany Cook
[email protected]
662-620-6853
Barry Bertolet, MD (PRINCIPAL_INVESTIGATOR)
Benjamin Blossom, MD (SUB_INVESTIGATOR)
Jonathan Blossom, MD (SUB_INVESTIGATOR)
Renown Regional Medical CenterRenoNevada89502
Kristen Gurnea, MPH
[email protected]
Lisa English, BS
[email protected]
Michael Bloch, MD (PRINCIPAL_INVESTIGATOR)
Virtua Our Lady of Lourdes HospitalCamdenNew Jersey08103
Kristin Broderick, BS
[email protected]
609-969-1175
Kintur Sanghvi, MD (PRINCIPAL_INVESTIGATOR)
Baylor Heart & Vascular HospitalDallasTexas75226
Merielle H. Boatman, MBA
[email protected]
214-820-2273
Cara East, MD (PRINCIPAL_INVESTIGATOR)
UT Health East TexasTylerTexas75701
Elizabeth Seal, BSc, CCRC
[email protected]
903-510-7291
Frank Navetta, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Stanford Hospital and Clinics· Stanford, CAOrlando Health Heart & Vascular Institute· Orlando, FLBayCare Health System Mease Countryside Hospital· Safety Harbor, FLPiedmont Heart Institute· Atlanta, GABeth Israel Deaconess Medical Center· Boston, MAHenry Ford Providence Hospital· Southfield, MI

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