Uncontrolled Essential Hypertension
Conditions
Keywords
Ultrasound Ablation Catheter, Renal Sympathetic Denervation
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.
Interventions
DEVICEdisposable intravascular ultrasound ablation catheter and ultrasound ablation instrument
Disposable intravascular ultrasound ablation catheters (used with an ultrasound ablation instrument) can use ultrasound energy to block sympathetic activity in the renal arteries.
Sponsors
Lepu Medical Technology (Beijing) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | Before discharge (post-procedure), up to 7 days | Procedural success was defined as the absence of renal arterial related complication during the subject's hospitalization based on the device success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in average 24-hour/daytime/night-time ambulatory Diastolic Blood Pressure (DBP) | 1 month, 2months, 6 months post-procedure | — |
| Change in average daytime ambulatory Systolic Blood Pressure (SBP) | 1 month, 2months, 6 months post-procedure | — |
| Change in office systolic blood pressure | 1 month, 2 months, 6 months post-procedure | — |
| Change in office diastolic blood pressure | 1 month, 2 months, 6 months post-procedure | — |
| Device success | immediate post-procedure | — |
| Incidence of achieving target office systolic blood pressure | 1 month, 2 months, 6 months post-procedure | — |
| Significant embolic events resulting in end-organ damage | 1 month, 2 months, 6 months post-procedure | — |
| Change in average 24-hour/night-time ambulatory Systolic Blood Pressure (SBP) | 1 month, 2months, 6 months post-procedure | — |
| End-stage renal disease | 1 month, 2 months, 6 months post-procedure | — |
| Renal artery or vascular complications requiring intervention | 1 month, 2 months, 6 months post-procedure | — |
| Significant (50%) and severe (75%) new onset renal stenosis | 6 months post-procedure | — |
| Severe access site complications | 1 month, 2 months, 6 months post-procedure | — |
| Incidence of adverse events | 1 month, 2 months, 6 months post-procedure | — |
| Stability of ultrasonic ablation instrument | immediate post-procedure | Whether the instrument has failed during the use of the device, and whether the fault can be recovered. |
| Interface friendliness of ultrasonic ablation instrument | immediate post-procedure | It is defined as whether the operation interface and difficulty of operation of the instrument are convenient. |
| Incidence of acute myocardial infarction, stroke, transient ischemic attack, cerebrovascular accident | 1 month, 2 months, 6 months post-procedure | — |
Countries
China
Contacts
Primary ContactTing Zhang
Outcome results
None listed