RecruitingNCT07081243
Symplicity China Study
A Prospective, Single-group, Non-interventional, Non-blinded, Observational Study to Evaluate the Long-term Safety, Efficacy, and Durability of Symplicity Spyral Renal Denervation System in China
Sponsor
Medtronic Vascular
Enrollment
500 participants
Start Date
Nov 11, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- Aged 18 years or older.
- Patients diagnosed with resistant hypertension or antihypertensive drug intolerance and treated with Symplicity Spyral Renal Denervation System. Resistant hypertension, defined as having an office systolic blood pressure (SBP) ≥140 mmHg despite appropriate lifestyle measures and being treated with three or more antihypertensive medications (including a diuretic) for more than 3 months; or drug intolerance, defined as patients who cannot tolerate medication due to contraindications or adverse effects.
- The patient voluntarily undergoes renal denervation; the patient has been informed of the observational nature of the study; the patient voluntarily provides written informed consent ("Patient Informed Consent Form") and willingly participates in the study.
Exclusion Criteria8
- At least one main renal artery with a diameter less than 3 mm or greater than 8 mm.
- Presence of fibromuscular dysplasia.
- Renal artery stent placement within 3 months prior to the procedure.
- Presence of Renal artery aneurysms.
- Presence of more than 50% stenosis in any treatable vessel.
- Pregnant.
- Present of renal or adrenal tumors.
- Iliac/femoral artery stenosis prevents catheter insertion.
Interventions
DEVICESymplicity Spyral Renal Denervation System
Symplicity Renal Denervation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07081243
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