Ultrasound Ablation for Essential Hypertension(FIM)

Last updated: March 21, 2023
Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Stress

High Blood Pressure (Hypertension - Pediatric)

Treatment

N/A

Clinical Study ID

NCT05795829
LPCTP-2021-004
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 weeksbefore randomization and the prescribed dose should be ≥ 50% of the manufacturer'smaximum dose, angiotensin-converting enzyme inhibitor (ACEI) (or angiotensin-Ⅱreceptor 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 bloodpressure (DBP) ≥90mmHg;
  1. 24-hour ambulatory systolic blood pressure: ≥135 mmHg and <170 mmHg;
  2. A recorded history of essential hypertension;
  3. Understands the purpose of this study, and is willing to sign the Informed Consent andcomplete clinical follow-up.

Exclusion

Exclusion Criteria:

  1. Ineligible renal artery anatomy including : (1) multiple renal arteries, (2) mainrenal artery diameter <4mm or length <20mm, (3) renal artery stenosis > 50% in themain renal artery, (4) atherosclerosis of the renal artery, renal artery aneurysm,fibromuscular dysplasia or calcification, (5) pre-existing renal stent, (6) singlekidney
  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 asplasma Hb1Ac≥ 9.0% or 24-hour urinary protein quantification >1g/24h or proliferativeretinopathy)
  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 mechanicalventilation 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 completedtheir primary endpoint
  11. Subjects who are allergic to contrast medium
  12. Subjects who are unsuitable for the trial ,because of poor patient compliance or otherreasons judged by the investigator

Study Design

Total Participants: 10
Study Start date:
January 16, 2023
Estimated Completion Date:
February 29, 2024

Study 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.

Connect with a study center

  • The Second Affiuated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin,
    China

    Active - Recruiting

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