AzTrials
AzTrials

Uncontrolled Essential HypertensionNCT05795829

Ultrasound Ablation for Essential Hypertension（FIM）

A study testing disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument in people with Uncontrolled Essential Hypertension, run by Lepu Medical Technology (Beijing) Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To evaluate the safety and feasibility of disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument in the treatment of essential hypertension. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Uncontrolled Essential Hypertension
What is being tested?
disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesChina
Study dates
16 Jan 2023to 29 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Ting Zhang contact

010-80120666

ting_zhang@lepumedical.com

China2 sites, 2 recruiting

  • The Second Affiuated Hospital of Chongqing Medical University

    Chongqing

    Jing huang, 023-63693083

    Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin

    Bo Yu, 0451-86605180

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument
Keywords
Ultrasound Ablation Catheter, Renal Sympathetic Denervation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • disposable intravascular ultrasound ablation catheter and ultrasound ablation instrumentDevice

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

Study groups in NCT05795829
Study groupRoleWhat they receive
Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation InstrumentExperimentalAll subjects will receive treatment from the disposable intravascular ultrasound ablation catheter.
Receives: Device: disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (16)

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

    Measured: 1 month, 2months, 6 months post-procedure

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

    Measured: 1 month, 2months, 6 months post-procedure

  3. Change in average daytime ambulatory Systolic Blood Pressure (SBP)

    Measured: 1 month, 2months, 6 months post-procedure

  4. Change in office systolic blood pressure

    Measured: 1 month, 2 months, 6 months post-procedure

  5. Change in office diastolic blood pressure

    Measured: 1 month, 2 months, 6 months post-procedure

  6. Device success

    Measured: immediate post-procedure

  7. Incidence of achieving target office systolic blood pressure

    Measured: 1 month, 2 months, 6 months post-procedure

  8. Significant embolic events resulting in end-organ damage

    Measured: 1 month, 2 months, 6 months post-procedure

  9. Incidence of acute myocardial infarction, stroke, transient ischemic attack, cerebrovascular accident

    Measured: 1 month, 2 months, 6 months post-procedure

  10. End-stage renal disease

    Measured: 1 month, 2 months, 6 months post-procedure

  11. Renal artery or vascular complications requiring intervention

    Measured: 1 month, 2 months, 6 months post-procedure

  12. Significant (50%) and severe (75%) new onset renal stenosis

    Measured: 6 months post-procedure

  13. Severe access site complications

    Measured: 1 month, 2 months, 6 months post-procedure

  14. Incidence of adverse events

    Measured: 1 month, 2 months, 6 months post-procedure

  15. Stability of ultrasonic ablation instrument

    Whether the instrument has failed during the use of the device, and whether the fault can be recovered.

    Measured: immediate post-procedure

  16. Interface friendliness of ultrasonic ablation instrument

    It is defined as whether the operation interface and difficulty of operation of the instrument are convenient.

    Measured: immediate post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start16 Jan 2023
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion29 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05795829
Sponsor's protocol ID
LPCTP-2021-004
Status last verified
Mar 2023
First submitted
8 Mar 2023
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument in people with Uncontrolled Essential Hypertension, run by Lepu Medical Technology (Beijing) Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ting Zhang (010-80120666, ting_zhang@lepumedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success (time frame: Before discharge (post-procedure), up to 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05795829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in