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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLepu Medical Technology (Beijing) Co., Ltd.

About this trial

This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.

Eligibility criteria

Qualifiers

Aged ≥18 years and ≤75 years, regardless of gender.

Documented history of primary hypertension.

Office systolic blood pressure (SBP) ≥150 mmHg and <180 mmHg;

Office diastolic blood pressure (DBP) ≥90 mmHg;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intravascular Ultrasound Ablation Therapy
  • Renal Artery Angiography

Treatment groups

213 Participants
are divided into 2 treatment groups