Trials Sponsors Conditions Drugs Pricing

Conditions

Uncontrolled Essential Hypertension

Keywords

Ultrasound Ablation CatheterRenal Sympathetic Denervation

Outcome Measures

Primary Outcomes (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.
Before discharge (post-procedure), up to 7 days

Secondary Outcomes (16)

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
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
+11 more secondary outcomes

Study Arms (1)

Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument

EXPERIMENTAL

All subjects will receive treatment from the disposable intravascular ultrasound ablation catheter.

Device: disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument

Interventions

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.

Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;

Sponsors & Collaborators

Lepu Medical Technology (Beijing) Co., Ltd.
Industrylead

Study Sites (2)

The Second Affiuated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Jing huangCONTACT023-63693083

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

RECRUITING

Bo YuCONTACT0451-86605180

Study Officials

Bo Yu
The Second Affiliated Hospital of Harbin Medical University
STUDY CHAIR
Jing Huang
The Second Affiuated Hospital of Chongqing Medical University
STUDY CHAIR

Central Study Contacts

Ting Zhang

CONTACT

010-80120666 ting_zhang@lepumedical.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 3, 2023

Study Start

January 16, 2023

Actual (reported)

Primary Completion

December 31, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Ultrasound Ablation for Essential Hypertension（FIM）

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (1)

Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (1)

Disposable Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation Instrument

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations