NCT04248530CompletedNot Applicable
An Open-Label, Single Arm, Multicenter Feasibility Study to Evaluate the Safety of Catheter-Based Renal Denervation With the DENEX System in Patients With Uncontrolled Hypertension on Standard Medical Therapy
Kalos Medical6 sites in 1 country16 target enrollmentStarted: November 30, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 6
- Primary Endpoint
- Rate of all adverse events
Study Overview
Brief Summary
The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.
Detailed Description
DENEX system developed by Handok Kalos Medical Inc. is a renal nerve blocking 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individual is ≥ 20 years of age at time of consent
- •Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg
- •Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg
- •Individual maintains the following 3 antihypertensive medications: thiazide-type diuretic, calcium-channel blocker, and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (for at least 6 weeks before the screening visit) that is expected to be maintained without changes for at least 6 months.
Exclusion Criteria
- •Main renal artery contains renal artery stenosis >50%
- •Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram
- •Undergone prior renal angioplasty
- •Main renal arterial vessel for each kidney <4 and >8 mm in diameter, or <20 mm length
- •Individual has an Estimated glomerular filtration rate <45 mL/min/1.73 m2 at screening visit
- •Individual has experienced myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
- •Individual has Hemodynamically or echocardiography significant valvular heart disease
- •Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension)
- •Individual has documented primary pulmonary hypertension
- •Individual has orthostatic hypotension with symptom
- •Individual requires chronic oxygen support for sleep apnea
- •Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention
- •Individual has Type 1 diabetes mellitus
Outcomes
Primary Outcomes
Rate of all adverse events
Time Frame: From baseline to 1 month post-procedure
rate of major adverse events for 1 month after the treatment
Secondary Outcomes
- Percentage of decreased office SBP >10, 15, 20 mmHg(From baseline to 1, 3, 6, 12, 18, 24 months post-procedure)
- Office SBP change at 1, 3, 6, 12, 18, 24 months(From baseline to 1, 3, 6, 12, 18, 24 months post-procedure)
- Ambulatory SBP change at 3,6,12,24 months(From baseline to 3, 6, 12, 24 months post-procedure)
Investigators
Study Sites (6)
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