LEPU Renal Denervation System for Resistant Hypertension | NCT02536326

Studies
LEPU Renal Denervation System for Resistant Hypertension

NCT02536326

Sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Status

Completed

Last Update Posted

Sep 2, 2015Estimated

Enrollment

50Actual

Phase

Phase 3

Conditions

Hypertension
Cardiovascular Diseases
Vascular Diseases

Interventions

LEPU Renal Denervation System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Aug 27, 2015

First Submission Date that Met QC Criteria

Aug 27, 2015

First Posted Date

Aug 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2015

Last Update Posted Date

Sep 2, 2015Estimated

Name	Class
Chinese Academy of Medical Sciences, Fuwai Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of resistant hypertension in Chinese patients in a prospective cohort study.

Detailed Description

Currently, considerable data on RDN have been obtained from Western populations, while the clinical outcomes of RDN in East Asian populations are seldom reported. Therefore, the purpose was to evaluate 6-month outcomes of RDN for the treatment of resistant hypertension in Chinese patients.In a prospective single-center cohort study, 50 Chinese patients with resistant hypertension would be recruited to undergo RDN by LEPU Renal denervation system, which was similar to Symplicity the Symplicity renal-denervation system (Medtronic). The primary effectiveness endpoint was change in systolic and diastolic blood pressure at six months as measured by office-based blood pressure assessment and 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline. The primary safety endpoint was the incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%) that required stenting or surgery, cerebrovascular accident, myocardial infarction, death.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
renal denervation	Experimental		Device: LEPU Renal Denervation System

Name	Type	Description	Arm Group Labels	Other Names
LEPU Renal Denervation System	Device	LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)	renal denervation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: Reduction of systolic blood pressure(SBP) and diastolic blood pressure(DBP) at six months as measured by office-based blood pressure assessment and ambulatory blood pressure monitoring(ABPM) compared to baseline		6 months after RDN
2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)		through 6 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in 24-h ambulatory blood pressure(ABPM) parameters		1 month,3 months,6 months after RDN
Device or procedure related acute adverse events（Renal artery edema、mural thrombus，change in transcatheter blood pressure >20%,<20% compared to baseline、reduction of heart rate >20%）

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65 years
Stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to RDN)
1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour mean SBP and/or DBP ≥140 and/or 90 mmHg
Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
eGFR ≥45 mL/min/1.73 m2
Written informed consent

Exclusion Criteria:

Clinical Exclusion Criteria:
- Known secondary hypertension
- Type 1 diabetes mellitus
- Has an implantable cardioverter defibrillator (ICD) or pacemaker
- Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
- Widespread atherosclerosis with documented intravascular thrombosis or unstable plaques
- Has hemodynamically significant valvular heart disease
- Pregnant, nursing, or planning to be pregnant
- Any serious medical condition that may adversely affect the safety of the participant or the study
- Currently enrolled in another investigational drug or device trial
Anatomic Exclusion Criteria
- Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
- History of prior renal artery intervention including balloon angioplasty or stenting
- Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
- Main renal arteries with <4 mm diameter or with <20 mm treatable length (by visual estimation)
- Renal artery abnormalities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006973	Hypertension
D002318	Cardiovascular Diseases
D014652	Vascular Diseases