Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT01835535
Eligibility Criteria:
Inclusion Criteria:
* Patient is ≥ 18 and ≤ 80 years of age
* For Cohort A: Documented office systolic blood pressure \> 160 mmHg (\> 150 mmHg for diabetic patients); For Cohort B: Documented office systolic blood pressure \> 140 mmHg (\> 130 mmHg for diabetic patients); For Cohort C: Documented office systolic blood pressure \> 150 mmHg (\> 140 mmHg for diabetic patients)
* Documented 24 hour systolic ABPM \> 135 mmHg
* Adherence to a stable drug regimen
* For patients in Cohort C only: Documented renal denervation procedure with any RF technology 12 months or more prior to screening
* Suitable renal artery anatomy
* Male or non-pregnant / non-lactating female
* Patient understands the nature of the procedure and provides written informed consent
* Patient is willing and able to comply with the specified study requirements and follow-up evaluations
Exclusion Criteria:
* eGFR \< 45mL/min/1.73m2
* Documented primary pulmonary hypertension
* Patient experienced \>1 episode of orthostatic hypotension coupled with syncope
* Documented indicator of a secondary renal hypertension
* History of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months
* Planned major surgery or cardiovascular intervention in the next 6 months
* Surgery or cardiovascular intervention in the previous 3 months
* Hemodynamically significant valvular heart disease
* Severe debilitating lung disease
* Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization
* Patient has a single functioning kidney
* Documented thrombocytopenia, clotting disorders or aortic aneurysms
* Moribund patient, or patient with comorbidities limiting life expectancy to less than one year
* Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication
* Concurrent enrollment in another trial
* Main renal arteries \< 4 mm in lumen diameter or \< 20 mm in length
* Aorto-renal angle that prevents a safe cannulation of the renal artery
* Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure
* Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
* Any renal artery stenosis \> 50% by visual assessment
* Any renal artery aneurysm in either renal artery
* A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01835535
Study Brief:
Protocol Section:
NCT01835535