Phase
Condition
Stress
Vascular Diseases
Autonomic Nervous System
Treatment
Renal sympathetic denervation plus aorticorenal ganglion ablation
Renal sympathetic denervation
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and non-pregnant female subjects;
18≤age≤70 years old;
Primary hypertension;
24-hour ASBP ≥130mmHg after standard anti-hypertensive drug therapy;
Arteries meet the criteria of catheter manipulation;
Patient understands the purpose of this study, and is willing to participate andsign the informed consent;
Patient is compliant and willing to complete clinical follow-up.
Exclusion
Exclusion Criteria:
Abdominal aorta and renal arteries are not eligibility for catheter manipulation: 1)Renal artery stenosis >50% or any renal artery aneurysms on either side 2) Historyof renal artery percutaneous transluminal angioplasty (PTA), including balloonangioplasty and stenting; 3) abdominal aortic dissection, ulceration, or stenosis.
eGFR <45ml/min/1.73m2 (MDRD formula)
Hospitalized within one year due to hypertensive crisis
Participated other clinical trials including both drug and medical device studieswithin 3 months enrollment
Female with pregnant or lactating, or having plans for pregnancy within 1 year
Patient with sleep apnea who needs chronic oxygen-breathing or mechanicalventilation support (for example, tracheostomy)
Patients previously or currently suffering from one of the following diseases: 1)Essential pulmonary arterial hypertension; 2) Type I diabetes; 3) Severe cardiacvalvular stenosis; 4) History of myocardial infraction (MI), unstable angina,syncope or cerebrovascular accidents within half year; 5) History of primaryaldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism orhyperparathyroidism; 6) Any disease conditions interfering the measurement of bloodpressure (for instance, severe peripheral artery diseases, abdominal arteryaneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia and severeanemia); 7) Plans to have surgery or cardiovascular interventions within following 6months; 8) Alcohol abuse or unknown drug dependence history; 9) Neuroticisms such asdepression or anxiety disorders; 10) Non-compliant patients unable to finish theresearch per physician's requests.
Study Design
Study Description
Connect with a study center
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing 400072
ChinaSite Not Available

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