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SPYRAL DYSTAL Renal Denervation Global Clinical Study

N/A
Waitlist Available
Led By David P Lee, MD
Research Sponsored by Medtronic Vascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (sv2) to 12 months post-procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a procedure called renal denervation, which disrupts nerves in the kidney arteries, can effectively lower blood pressure in patients who don't respond well to typical treatments. Renal denervation is a new approach that has been shown to effectively lower blood pressure in patients with resistant hypertension.

Eligible Conditions
  • High Blood Pressure
  • Cardiovascular Disease
  • Vascular Disease
  • Chorioretinal Vascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (sv2) to 12 months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (sv2) to 12 months post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
Incidence of Major Bleeding According to TIMI Definition
+2 more
Other study objectives
Office Diastolic Blood Pressure (DBP) Reduction
Office Systolic Blood Pressure (SBP) Reduction
Procedural Characteristics: Amount of Contrast Used (cc)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renal DenervationExperimental Treatment1 Intervention
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Denervation (Symplicity Spyral™)
2020
N/A
~130

Find a Location

Who is running the clinical trial?

Medtronic VascularLead Sponsor
66 Previous Clinical Trials
57,339 Total Patients Enrolled
David P Lee, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
4,199 Total Patients Enrolled
Andrew Sharp, MDPrincipal InvestigatorUniversity Hospital of Wales
1 Previous Clinical Trials
1,500 Total Patients Enrolled
~23 spots leftby Dec 2025
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