To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension

Korábbi kezelés

• Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.
• Prior Renal Artery Denervation Procedure.

Más betegség

• Diagnosis of Type 1 Diabetes Mellitus.
• Suspected Secondary Hypertension.
• Allergy to Contrast Agents.

Laborértékek

• Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m².

Egyéb

• Unsuitable Renal Artery Anatomy for Treatment
  • Main renal artery diameter <4 mm or length <20 mm.
  • Accessory renal artery diameter ≥ 2 mm and <4 mm.
  • Renal artery stenosis >50% in the main renal artery.
  • Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.
  • Presence of a renal artery stent.
  • Single kidney.
• Orthostatic Hypotension.
• Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea).
• Life Expectancy <1 Year.
• Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months.
• Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint.
• Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).

• Aged ≥18 years and ≤75 years, regardless of gender.
• Documented history of primary hypertension.
• Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB) or a triple combination of ARB/CCB plus a diuretic agent . After at least 4 consecutive weeks of screening, blood pressure must meet the following criteria:
  • Office systolic blood pressure (SBP) ≥150 mmHg and <180 mmHg;
  • Office diastolic blood pressure (DBP) ≥90 mmHg;
  • 24-hour ambulatory systolic blood pressure ≥135 mmHg and <170 mmHg.
• Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.