Ultrasound Ablation for Essential Hypertension（FIM）

Lepu Medical Technology

Status

Enrolling

Conditions

Uncontrolled Essential Hypertension

Treatments

Device: disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument

Study type

Interventional

Funder types

Industry

Identifiers

NCT05795829

LPCTP-2021-004

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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;
24-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.

Exclusion criteria

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