Ultrasound Ablation for Essential Hypertension（FIM）

NCT05795829 | Unknown

• 1 other identifier: LPCTP-2021-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the safety and feasibility of disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument in the treatment of essential hypertension.

Conditions

Uncontrolled Essential Hypertension

Keywords

Ultrasound Ablation Catheter; Renal Sympathetic Denervation

Outcome Measures

Primary Outcomes (1)

• Procedural success

  Procedural success was defined as the absence of renal arterial related complication during the subject's hospitalization based on the device success.

  Before discharge (post-procedure), up to 7 days

Secondary Outcomes (16)

• Change in average 24-hour/night-time ambulatory Systolic Blood Pressure (SBP)

  1 month, 2months, 6 months post-procedure

• Change in average 24-hour/daytime/night-time ambulatory Diastolic Blood Pressure (DBP)

  1 month, 2months, 6 months post-procedure

• Change in average daytime ambulatory Systolic Blood Pressure (SBP)

  1 month, 2months, 6 months post-procedure

• Change in office systolic blood pressure

  1 month, 2 months, 6 months post-procedure

• Change in office diastolic blood pressure

  1 month, 2 months, 6 months post-procedure

Study Arms (1)

Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument

EXPERIMENTAL

All subjects will receive treatment from the disposable intravascular ultrasound ablation catheter.

Device: disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument

Interventions

disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument DEVICE

Disposable intravascular ultrasound ablation catheters (used with an ultrasound ablation instrument) can use ultrasound energy to block sympathetic activity in the renal arteries.

Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 and≤80 years old, no gender limitation;
• Two or more antihypertensive drugs should be statically taken for at least 4 weeks before randomization and the prescribed dose should be ≥ 50% of the manufacturer's maximum dose， angiotensin-converting enzyme inhibitor (ACEI) (or angiotensin-Ⅱ receptor antagonist (ARB)) and calcium channel blocker (CCB) (or thiazide diuretic) are required to be used in combination. Blood pressure meets the following conditions: 1) office systolic blood pressure (SBP)≥150mmHg and\<180mmHg; 2) office diastolic blood pressure (DBP) ≥90mmHg;
• hour ambulatory systolic blood pressure: ≥135 mmHg and \<170 mmHg;
• A recorded history of essential hypertension;
• Understands the purpose of this study, and is willing to sign the Informed Consent and complete clinical follow-up.

You may not qualify if:

• Ineligible renal artery anatomy including : (1) multiple renal arteries, (2) main renal artery diameter \<4mm or length \<20mm, (3) renal artery stenosis \> 50% in the main renal artery, (4) atherosclerosis of the renal artery, renal artery aneurysm, fibromuscular dysplasia or calcification, (5) pre-existing renal stent, (6) single kidney
• Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2
• Type Ⅰ diabetes mellitus or poorly controlled type Ⅱ diabetes mellitus (defined as plasma Hb1Ac≥ 9.0% or 24-hour urinary protein quantification \>1g/24h or proliferative retinopathy)
• Postural hypotension
• Recent vascular events: Experienced acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months of the screening period
• Possible secondary hypertension
• Respiratory support: The individual requires long-term oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
• Life expectancy \<1 year
• Female who is pregnant, nursing, or planning to become pregnant
• Subjects who are currently enrolled in another clinical trial and have not completed their primary endpoint
• Subjects who are allergic to contrast medium
• Subjects who are unsuitable for the trial ，because of poor patient compliance or other reasons judged by the investigator

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (2)

The Second Affiuated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

RECRUITING

Study Officials

• Bo Yu

  The Second Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

• Jing Huang

  The Second Affiuated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Ting Zhang

CONTACT

010-80120666; ting_zhang@lepumedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: January 16, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 29, 2024
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

CN (2)