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SPYRAL DYSTAL Renal Denervation Global Clinical Study

NCT04311086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-04-17

Study results available
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Summary

The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach used in the SPYRAL HTN-OFF MED clinical study.

Conditions

Interventions

DEVICE

Renal Denervation (Symplicity Spyral™)

Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • David P Lee, MD · Stanford University

  • Andrew Sharp, MD · University Hospital of Wales

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2022-12-22
Completion
2022-12-22
FDA Device
Yes

Countries

  • United States
  • Germany
  • Greece
  • 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 NCT04311086 on ClinicalTrials.gov