Ultrasound Ablation for Essential Hypertension（FIM）

NCT ID: NCT05795829

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2024-02-29

Brief Summary

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

Detailed Description

Feasibility Research This is a prospective, small-sample, single-group study. A total of 10 subjects are planned to be included in this study. Disposable intravascular catheter and instrument are used for intravascular ultrasound ablation. All participants will be followed up by telephone or outpatient at 1, 2 and 6 months post-procedure, with procedural success rate as the primary endpoint. At the same time, the incidence of adverse events will be observed to make a preliminary evaluation of the safety and feasibility of disposable intravascular catheter and instrument, and to provide data support for the second-stage confirmatory study.

In feasibility research, statistical analysis of data will be performed after 30 days postoperative follow-up of the subjects, and the safety and feasibility of disposable intravascular catheter and instrument will be preliminarily evaluated before entering the stage of confirmatory trial.

Conditions

Uncontrolled Essential Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument

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

Group Type: EXPERIMENTAL

disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument

Intervention Type: DEVICE

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

Interventions

disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age≥18 and≤80 years old, no gender limitation;

2. 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;

3. 24-hour ambulatory systolic blood pressure: ≥135 mmHg and <170 mmHg;

4. A recorded history of essential hypertension;

5. Understands the purpose of this study, and is willing to sign the Informed Consent and complete clinical follow-up.

Exclusion Criteria

1. 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

2. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2

3. 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)

4. Postural hypotension

5. Recent vascular events: Experienced acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months of the screening period

6. Possible secondary hypertension

7. Respiratory support: The individual requires long-term oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea

8. Life expectancy <1 year

9. Female who is pregnant, nursing, or planning to become pregnant

10. Subjects who are currently enrolled in another clinical trial and have not completed their primary endpoint

11. Subjects who are allergic to contrast medium

12. Subjects who are unsuitable for the trial ，because of poor patient compliance or other reasons judged by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lepu Medical Technology (Beijing) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bo Yu

Role: STUDY_CHAIR

The Second Affiliated Hospital of Harbin Medical University

Jing Huang

Role: STUDY_CHAIR

The Second Affiuated Hospital of Chongqing Medical University

Locations

The Second Affiuated Hospital of Chongqing Medical University

Chongqing, , China

Site Status: RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Zhang

Role: CONTACT

ting_zhang@lepumedical.com

010-80120666

Facility Contacts

Jing huang

Role: primary

023-63693083

Bo Yu

Role: primary

0451-86605180

Other Identifiers

LPCTP-2021-004

Identifier Type: -

Identifier Source: org_study_id