Clinical trial NCT05795829: Ultrasound Ablation for Essential Hypertension（FIM）
Official title: First in Man Study to Evaluate the Safety and Efficacy of Disposable Intravascular Ultrasound Ablation Catheters and Ultrasound Ablation Instrument in the Treatment of Essential Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uncontrolled Essential Hypertension
Keywords: Ultrasound Ablation Catheter
Renal Sympathetic Denervation
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Procedural success
timeFrame: Before discharge (post-procedure), up to 7 days
Secondary outcomes:
measure: Change in average 24-hour/night-time ambulatory Systolic Blood Pressure (SBP)
timeFrame: 1 month, 2months, 6 months post-procedure
measure: Change in average 24-hour/daytime/night-time ambulatory Diastolic Blood Pressure (DBP)
timeFrame: 1 month, 2months, 6 months post-procedure
measure: Change in average daytime ambulatory Systolic Blood Pressure (SBP)
timeFrame: 1 month, 2months, 6 months post-procedure
measure: Change in office systolic blood pressure
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: Change in office diastolic blood pressure
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: Device success
timeFrame: immediate post-procedure
measure: Incidence of achieving target office systolic blood pressure
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: Significant embolic events resulting in end-organ damage
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: Incidence of acute myocardial infarction, stroke, transient ischemic attack, cerebrovascular accident
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: End-stage renal disease
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: Renal artery or vascular complications requiring intervention
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: Significant (50%) and severe (75%) new onset renal stenosis
timeFrame: 6 months post-procedure
measure: Severe access site complications
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: Incidence of adverse events
timeFrame: 1 month, 2 months, 6 months post-procedure
measure: Stability of ultrasonic ablation instrument
timeFrame: immediate post-procedure
measure: Interface friendliness of ultrasonic ablation instrument
timeFrame: immediate post-procedure
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiuated Hospital of Chongqing Medical University
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu
role: STUDY_CHAIR
affiliation: The Second Affiuated Hospital of Chongqing Medical University
name: Jing Huang
role: STUDY_CHAIR
References: