Treatment of Resistant Hypertension by Renal Denervation in China (REDUCE-HTN-CN)

Boston Scientific

Status

Terminated

Conditions

Medication-resistant Hypertension

Treatments

Device: Percutaneous renal denervation with the Vessix™ Renal Denervation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02027012

S6007

Details and patient eligibility

About

REDUCE-HTN-China study is a prospective, multi-center, single cohort study for the percutaneous therapeutic treatment of medication-resistant hypertension in China.The primary objective is to assess the efficacy performance of the Vessix™ Renal Denervation System for the treatment of medication resistant hypertension on the basis of the hypothesis that the percutaneous therapeutic renal denervation for the treatment of medication-resistant hypertension using the Vessix™ Renal Denervation System will reduce systolic (SBP) and diastolic blood pressure (DBP) at 6- month compared to baseline as accessed by office-based blood pressure measurements.

Full description

The Vessix System is a highly-differentiated and advanced renal denervation system that features an intuitive push-button interface, a short 30-second treatment time and an over-the-wire, balloon-based approach familiar to most cardiac and vascular specialists. The Vessix System has both CE Mark and TGA approval and is currently available for sale in Europe, the Middle East, Australia, New Zealand and selected markets in Asia. The Vessix System is an investigational device and not available for sale in China. An current analysis of the REDUCE-HTN post market study affirms the device's safety profile and effective treatment for resistant hypertension.

Enrollment

1 patient

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have provided written informed consent
Are ≥ 18 years and ≤ 75 years of age
Have a SBP /DBP ≥ 160/90 mm Hg based on an average of three office-based blood pressure readings (seated) measured according to the protocol (≥ 150 mmHg in subjects with Type 2 diabetes)
On a stable medication regimen with ≥ 3 anti-hypertensive drugs (one of medications should be a diuretic, unless subject has a documented intolerance to diuretics) at maximally tolerated doses and have had no changes to the medication regimen two (2) weeks prior to enrollment
With a eGFR ≥ 40 ml/min per 1.73m²
Are willing and able to comply with all study procedures
With a main renal artery diameter of ≥ 3.5 mm and ≤ 7.0 mm for each of their kidneys
With a main renal artery without significant stenosis (stenosis defined as < 30%)
With a renal artery length of ≥ 15 mm

Exclusion criteria

With secondary hypertension
With Type I Diabetes Mellitus
Are contraindicated for intravascular contrast material
Are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure
With known bleeding or hyper-coagulation disorders
Have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
Have planned percutaneous vascular or surgical intervention for any reason within the next 6 months
Have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
Have an implantable cardioverter defibrillator (ICD) or pacemaker or with a clinically significant abnormal electrocardiogram at time of screening
Have any serious medical condition, which in the opinion of the investigator, may adversely affect subject safety or the efficacy of the procedure in the study (i.e., subjects with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders)
Are pregnant, nursing or planning to become pregnant or who are currently taking estrogen or any estrogen-like compound (female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to the procedure)
Have a known, unresolved history of drug use or alcohol abuse/dependency
Are currently enrolled in any investigational study wherein subject participation has not been completed
For any reason, may not be able to understand or comply with instructions
With only one kidney
With prior renal denervation procedure
With prior intervention to right or left renal artery
With renal artery stenosis as defined by ≥ 30% stenosis confirmed by angiography with two (2) orthogonal views with selective catheterization
With iliac stenosis requiring intervention at time of procedure and/or within the next six (6) months
With severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure
The physician is unable to cannulate the renal artery
The physician is unable to access the femoral artery by percutaneous means