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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01520506
Eligibility Criteria:
Inclusion Criteria:
1. Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
2. Age 18-85 years.
3. Able to provide informed consent and comply with follow-up visits.
Exclusion Criteria:
1. Diameter of left or right renal artery less than 4 mm or greater than 7mm.
2. Length of target segment of left or right renal artery less than 20mm.
3. Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
4. End-stage renal disease requiring dialysis or renal transplant.
5. estimated Glomerular Filtration Rate \< 45 mL/min per 1.73 m2.
6. Type 1 diabetes mellitus.
7. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
8. Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.
9. Bleeding disorder or refusing blood transfusions.
10. Pregnancy or breast feeding.
11. Peripheral vascular disease precluding catheter insertion.
12. Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
13. Current enrollment in another investigational drug or device Study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01520506
Study Brief:
Protocol Section:
NCT01520506