To evaluate the safety and feasibility of disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument in the treatment of essential hypertension.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Disposable intravascular ultrasound ablation catheters (used with an ultrasound ablation instrument) can use ultrasound energy to block sympathetic activity in the renal arteries.
The Second Affiuated Hospital of Chongqing Medical University
Chongqing, China
RECRUITINGThe Second Affiliated Hospital of Harbin Medical University
Harbin, China
RECRUITINGProcedural success
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
Change in average 24-hour/night-time ambulatory Systolic Blood Pressure (SBP)
Time frame: 1 month, 2months, 6 months post-procedure
Change in average 24-hour/daytime/night-time ambulatory Diastolic Blood Pressure (DBP)
Time frame: 1 month, 2months, 6 months post-procedure
Change in average daytime ambulatory Systolic Blood Pressure (SBP)
Time frame: 1 month, 2months, 6 months post-procedure
Change in office systolic blood pressure
Time frame: 1 month, 2 months, 6 months post-procedure
Change in office diastolic blood pressure
Time frame: 1 month, 2 months, 6 months post-procedure
Device success
Time frame: immediate post-procedure
Incidence of achieving target office systolic blood pressure
Time frame: 1 month, 2 months, 6 months post-procedure
Significant embolic events resulting in end-organ damage
Time frame: 1 month, 2 months, 6 months post-procedure
Incidence of acute myocardial infarction, stroke, transient ischemic attack, cerebrovascular accident
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Time frame: 1 month, 2 months, 6 months post-procedure
End-stage renal disease
Time frame: 1 month, 2 months, 6 months post-procedure
Renal artery or vascular complications requiring intervention
Time frame: 1 month, 2 months, 6 months post-procedure
Significant (50%) and severe (75%) new onset renal stenosis
Time frame: 6 months post-procedure
Severe access site complications
Time frame: 1 month, 2 months, 6 months post-procedure
Incidence of adverse events
Time frame: 1 month, 2 months, 6 months post-procedure
Stability of ultrasonic ablation instrument
Whether the instrument has failed during the use of the device, and whether the fault can be recovered.
Time frame: immediate post-procedure
Interface friendliness of ultrasonic ablation instrument
It is defined as whether the operation interface and difficulty of operation of the instrument are convenient.
Time frame: immediate post-procedure