Health TrialsbyHealthPanel

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

ConditionEssential 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Intravascular Ultrasound Ablation Therapy

    Procedure/Surgery

    The single-use intravascular ultrasound ablation catheter is used in conjunction with the ultrasound ablation device to remove renal sympathetic nerves. Standardized medication regimen.

  • Renal Artery Angiography

    Procedure/Surgery

    Only undergo renal artery angiography. Standardized medication regimen.

Treatment groups

213 Participants
are divided into 2 treatment groups
Group A: Renal denervation (RDN) GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure]

Time frame
From baseline to 6 months

Secondary outcomes

1

Change in Daytime/Nighttime Average Ambulatory Systolic Blood Pressure (SBP)

Time frame
1 Month, 2 Months, and 6 Months Post-Procedure
2

Change in 24-Hour/Daytime/Nighttime Average Ambulatory Diastolic Blood Pressure (DBP)

Time frame
1 Month, 2 Months, and 6 Months Post-Procedure
3

Change in 24-Hour Average Ambulatory Systolic Blood Pressure (SBP)

Time frame
1 Month and 2 Months Post-Procedure
4

Change in Office Systolic Blood Pressure

Time frame
1 Month, 2 Months, and 6 Months Post-Procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lepu Medical Technology (Beijing) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now