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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument | Experimental | All subjects will receive treatment from the disposable intravascular ultrasound ablation catheter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument | Device | Disposable intravascular ultrasound ablation catheters (used with an ultrasound ablation instrument) can use ultrasound energy to block sympathetic activity in the renal arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Procedural success was defined as the absence of renal arterial related complication during the subject's hospitalization based on the device success. | Before discharge (post-procedure), up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average 24-hour/night-time ambulatory Systolic Blood Pressure (SBP) | 1 month, 2months, 6 months post-procedure | |
| Change in average 24-hour/daytime/night-time ambulatory Diastolic Blood Pressure (DBP) | 1 month, 2months, 6 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Zhang | Contact | 010-80120666 | ting_zhang@lepumedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Yu | The Second Affiliated Hospital of Harbin Medical University | Study Chair |
| Jing Huang | The Second Affiuated Hospital of Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiuated Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
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| 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 |
| Incidence of acute myocardial infarction, stroke, transient ischemic attack, cerebrovascular accident | 1 month, 2 months, 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 | Whether the instrument has failed during the use of the device, and whether the fault can be recovered. | 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. | immediate post-procedure |
| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | China |
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