A Prospective, Multicenter, Sham-controlled, Single-blinded, Randomized, Pilot Study to Evaluate the Safety and Effectiveness of DENEX Renal Denervation System in Patients With Uncontrolled Hypertension Not Treated With Anti-HTN Medication

Kalos Medical1 site in 1 country100 target enrollmentOctober 20, 2022

ConditionsHypertension Vascular Diseases Cardiovascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: Kalos Medical
Enrollment: 100
Locations: 1
Primary Endpoint: Change in 24-h ambulatory systolic blood pressure
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of renal denervation using DENEX System in patients with hypertension without antihypertensive medication, compared with the sham group.

Detailed Description

DENEX system developed by Kalos Medical Inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

Registry

clinicaltrials.gov

Start Date

October 20, 2022

End Date

April 15, 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kalos Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject aged 18 to 80 years old at the time of signing the informed consent
•Subject who is drug-naïve or willing to discontinue current antihypertensive treatment (not on antihypertensive medications for at least 4 weeks prior to Screening Visit 1) at Screening Visit 1 through the 3-month post-procedure visit. Drug-naïve is defined as those with no previous exposure to antihypertensive medications.
•Subject who meets all of the following blood pressure measurements:
•Office Systolic Blood Pressrue (SBP) \< 180 mmHg at Screening Visit 1
•Office SBP ≥ 150 mmHg and \< 180 mmHg, and office diastolic blood pressure (DBP) ≥ 90 mmHg at Screening Visit 2
•24-h ambulatory SBP ≥ 140 mmHg and \< 170 mmHg at Screening Visit 2
•Subject who voluntarily decides to participate in this clinical study and sign the written consent.
•Subject who willing and able to complete all clinical investigation-related procedures and assessments

Exclusion Criteria

•Subject with renal anatomy that is ineligible for treatment:
•Diameter of main renal artery for each kidney is \< 3 mm or \> 8 mm OR presence of accessory renal arteries (ARAs) with a diameter \< 3 mm
•Presence of fibromuscular dysplasia
•Presence of kidney tumors or secretory tumors in the adrenal gland
•\> 50% stenosis in any treatable vessel
•Presence of aneurysm (any localized increase in vessel diameter)
•Treatment area within 5 mm segment in the renal artery contains an atheroma, calcification, or a renal artery stent
•A single functioning kidney
•Polycystic kidney disease
•Subject with prior renal denervation, renal artery stenting, renal artery angioplasty, renal nephrectomy, or renal transplant

Outcomes

Primary Outcomes

Change in 24-h ambulatory systolic blood pressure

Time Frame: from baseline to 3 months post-procedure

Change in 24-h ambulatory systolic blood pressure from baseline to 3 months post-procedure

Incidence of MAE within 3 months post-procedure

Time Frame: within 3 months post-procedure

Incidence of MAE within 3 months post-procedure

Secondary Outcomes

Changes in 24-h ambulatory systolic blood pressure(from baseline to 6, 12, and 24 months post-procedure)
Changes in office diastolic blood pressure(from baseline to 1, 3, 6, 12, and 24 months post-procedure)
Incidence of achieving target office systolic blood pressure (< 140 mmHg)(from baseline to 1, 3, 6, 12, and 24 months post-procedure)
Incidence of AEs, SAEs, ADE, and SADE(at 1, 3, 6, 12, and 24 months post-procedure)
Incidence of all-cause mortality(at 3, 6, 12, and 24 months post-procedure)
Incidence of major bleeding according to Thrombolysis in Myocardial Infarction (TIMI) definition(at 1, 3, 6, 12, and 24 months post-procedure)
Incidence or increase in serum creatinine > 50%(at 1, 3, 6, 12, and 24 months post-procedure)
Changes in 24-h ambulatory diastolic blood pressure(from baseline to 3, 6, 12, and 24 months post-procedure)
Changes in office systolic blood pressure(from baseline to 1, 3, 6, 12, and 24 months post-procedure)
Incidence of MAE(at 6, 12, and 24 months post-procedure)
Incidence of end-stage renal disease, incidence of ≥ 40% decline in eGFR, incidence of new myocardial infarction, incidence of new stroke, incidence of renal artery reintervention(at 1, 3, 6, 12, and 24 months post-procedure)
Changes in heart rate(from baseline to 3, 6, 12, and 24 months post-procedure)
Incidence of significant embolic event resulting in end-organ damage, incidence of renal artery perforation requiring intervention, incidence of renal artery dissection requiring intervention, incidence of vascular complications(at 1 month post-procedure)
Incidence of new renal artery stenosis > 70%(at 3 months post-procedure)
Incidence of hospitalization for hypertensive crisis not related to confirmed non-adherence or the CIP(at 1, 3, 6, 12, and 24 months post-procedure)