Back to resultsUltrasound Ablation for Essential Hypertension（FIM）
Primary Purpose
Uncontrolled Essential Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument
Sponsored by
About this trial
This is an interventional treatment trial for Uncontrolled Essential Hypertension focused on measuring Ultrasound Ablation Catheter, Renal Sympathetic Denervation
Eligibility Criteria
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
Sites / Locations
- The Second Affiuated Hospital of Chongqing Medical UniversityRecruiting
- The Second Affiliated Hospital of Harbin Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument
Arm Description
All subjects will receive treatment from the disposable intravascular ultrasound ablation catheter.
Outcomes
Primary Outcome Measures
Procedural success
Procedural success was defined as the absence of renal arterial related complication during the subject's hospitalization based on the device success.
Secondary Outcome Measures
Change in average 24-hour/night-time ambulatory Systolic Blood Pressure (SBP)
Change in average 24-hour/daytime/night-time ambulatory Diastolic Blood Pressure (DBP)
Change in average daytime ambulatory Systolic Blood Pressure (SBP)
Change in office systolic blood pressure
Change in office diastolic blood pressure
Device success
Incidence of achieving target office systolic blood pressure
Significant embolic events resulting in end-organ damage
Incidence of acute myocardial infarction, stroke, transient ischemic attack, cerebrovascular accident
End-stage renal disease
Renal artery or vascular complications requiring intervention
Significant (50%) and severe (75%) new onset renal stenosis
Severe access site complications
Incidence of adverse events
Stability of ultrasonic ablation instrument
Whether the instrument has failed during the use of the device, and whether the fault can be recovered.
Interface friendliness of ultrasonic ablation instrument
It is defined as whether the operation interface and difficulty of operation of the instrument are convenient.
Full Information
NCT ID
NCT05795829
First Posted
March 8, 2023
Last Updated
March 21, 2023
Sponsor
Lepu Medical Technology (Beijing) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05795829
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lepu Medical Technology (Beijing) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Essential Hypertension
Keywords
Ultrasound Ablation Catheter, Renal Sympathetic Denervation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument
Arm Type
Experimental
Arm Description
All subjects will receive treatment from the disposable intravascular ultrasound ablation catheter.
Intervention Type
Device
Intervention Name(s)
disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument
Intervention Description
Disposable intravascular ultrasound ablation catheters (used with an ultrasound ablation instrument) can use ultrasound energy to block sympathetic activity in the renal arteries.
Primary Outcome Measure Information:
Title
Procedural success
Description
Procedural success was defined as the absence of renal arterial related complication during the subject's hospitalization based on the device success.
Time Frame
Before discharge (post-procedure), up to 7 days
Secondary Outcome Measure Information:
Title
Change in average 24-hour/night-time ambulatory Systolic Blood Pressure (SBP)
Time Frame
1 month, 2months, 6 months post-procedure
Title
Change in average 24-hour/daytime/night-time ambulatory Diastolic Blood Pressure (DBP)
Time Frame
1 month, 2months, 6 months post-procedure
Title
Change in average daytime ambulatory Systolic Blood Pressure (SBP)
Time Frame
1 month, 2months, 6 months post-procedure
Title
Change in office systolic blood pressure
Time Frame
1 month, 2 months, 6 months post-procedure
Title
Change in office diastolic blood pressure
Time Frame
1 month, 2 months, 6 months post-procedure
Title
Device success
Time Frame
immediate post-procedure
Title
Incidence of achieving target office systolic blood pressure
Time Frame
1 month, 2 months, 6 months post-procedure
Title
Significant embolic events resulting in end-organ damage
Time Frame
1 month, 2 months, 6 months post-procedure
Title
Incidence of acute myocardial infarction, stroke, transient ischemic attack, cerebrovascular accident
Time Frame
1 month, 2 months, 6 months post-procedure
Title
End-stage renal disease
Time Frame
1 month, 2 months, 6 months post-procedure
Title
Renal artery or vascular complications requiring intervention
Time Frame
1 month, 2 months, 6 months post-procedure
Title
Significant (50%) and severe (75%) new onset renal stenosis
Time Frame
6 months post-procedure
Title
Severe access site complications
Time Frame
1 month, 2 months, 6 months post-procedure
Title
Incidence of adverse events
Time Frame
1 month, 2 months, 6 months post-procedure
Title
Stability of ultrasonic ablation instrument
Description
Whether the instrument has failed during the use of the device, and whether the fault can be recovered.
Time Frame
immediate post-procedure
Title
Interface friendliness of ultrasonic ablation instrument
Description
It is defined as whether the operation interface and difficulty of operation of the instrument are convenient.
Time Frame
immediate post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Zhang
Phone
010-80120666
Email
ting_zhang@lepumedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yu
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jing Huang
Organizational Affiliation
The Second Affiuated Hospital of Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiuated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing huang
Phone
023-63693083
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Yu
Phone
0451-86605180
12. IPD Sharing Statement
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Ultrasound Ablation for Essential Hypertension（FIM）
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