Symplicity China Study

Last updated: November 13, 2025
Sponsor: Medtronic Vascular
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Diabetes And Hypertension

Vascular Diseases

Treatment

Symplicity Spyral Renal Denervation System

Clinical Study ID

NCT07081243
MDT24050
  • Ages > 18
  • All Genders

Study Summary

The Symplicity China study will evaluate the real-world long-term safety, efficacy, and durability of the Symplicity Spyral system in a population of approximately 500 renal denervation treated subjects with up to 36 months of follow up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 years or older.

  2. Patients diagnosed with resistant hypertension or antihypertensive drug intoleranceand treated with Symplicity Spyral Renal Denervation System. Resistant hypertension,defined as having an office systolic blood pressure (SBP) ≥140 mmHg despiteappropriate lifestyle measures and being treated with three or more antihypertensivemedications (including a diuretic) for more than 3 months; or drug intolerance,defined as patients who cannot tolerate medication due to contraindications oradverse effects.

  3. The patient voluntarily undergoes renal denervation; the patient has been informedof the observational nature of the study; the patient voluntarily provides writteninformed consent ("Patient Informed Consent Form") and willingly participates in thestudy.

Exclusion

Exclusion Criteria:

  1. At least one main renal artery with a diameter less than 3 mm or greater than 8 mm.

  2. Presence of fibromuscular dysplasia.

  3. Renal artery stent placement within 3 months prior to the procedure.

  4. Presence of Renal artery aneurysms.

  5. Presence of more than 50% stenosis in any treatable vessel.

  6. Pregnant.

  7. Present of renal or adrenal tumors.

  8. Iliac/femoral artery stenosis prevents catheter insertion.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Symplicity Spyral Renal Denervation System
Phase:
Study Start date:
November 11, 2025
Estimated Completion Date:
December 30, 2031

Connect with a study center

  • Zhongshan Hospital Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 210000
    China

    Active - Recruiting

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