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SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

NCT02439749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2025-03-28

Study results available
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Summary

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.

Conditions

Interventions

DEVICE

Symplicity Spyral™ multi-electrode renal denervation system

After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

PROCEDURE

Sham Procedure

After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • Raymond Townsend, MD · University of Pennsylvania

  • David Kandzari, MD · Piedmont Hospital

  • Michael Böhm, MD · Universitätskliniken des Saarlandes

  • Kazuomi Kario, MD · Jichi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2020-04-30
Completion
2023-10-25
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Germany
  • Greece
  • Ireland
  • Japan
  • United Kingdom

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 NCT02439749 on ClinicalTrials.gov