Please select the eligibility criteria that correspond to the clinical trial below.
Title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)
Brief Summary: The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.


Options:
A: Inclusion Criteria:

* \>= 18 years of age
* a systolic blood pressure of 160mmHg or more
* receiving and adhering to full doses of at least three antihypertensive drugs
* estimated glomerular filtration rate (eGFR) of ≥45mL/min
* agrees to have the study procedure(s) performed and additional procedures and evaluations
* is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

* hemodynamically or anatomically significant renal artery stenosis
* has a history or prior renal artery angioplasty
* has experienced MI, unstable angina pectoris, or CVA within 6 months
* has hemodynamically significant valvular heart disease
* has Type 1 diabetes
* has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
* requires respiratory support
* is pregnant, nursing, or planning to be pregnant
* has known, unresolved history of drug use or alcohol dependency.
* is currently enrolled in another investigational drug or device trial.
B: Inclusion Criteria:

1. Individual has a mean day-time SBP ≥ 135 mmHg, as determined with the use of ABPM, while using 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs ( ACE/ARB, Calcium channel blocker, Beta Blocker, Diuretic) and no possibility to take 3 anti-hypertensive drugs.
2. Individual is ≥18 years of age.

Exclusion Criteria:

1. Individual is unable or unwilling to sign informed consent.
2. Individual has a treatable secondary cause of hypertension.
3. Individual has an eGFR below 20 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) calculation.
4. Individual has renal artery anatomy that is ineligible for treatment
5. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
6. Individual is pregnant, nursing or planning to be pregnant.
7. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
8. Individual is currently enrolled in another investigational drug or device trial.
C: Inclusion Criteria:

* Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
* Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and \< 170 mmHg.

Exclusion Criteria:

* Individual lacks appropriate renal artery anatomy.
* Individual has estimated glomerular filtration rate (eGFR) of \<45.
* Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
* Individual has one or more episodes of orthostatic hypotension.
* Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to become pregnant.
* Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment
* Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
* Individual works night shifts.
D: Inclusion Criteria:

* Refractory hypertension: 3 or more antihypertensive agents of different classes (including a diuretic) at optimal dosage without change in the 4 weeks preceding randomization
* Systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmHg (ABPM mean daytime values)
* No change in blood pressure medication within 6 months after randomization
* Age 18 to 75 years
* Informed consent

Exclusion Criteria:

* Blood pressure outside range mentioned above
* Renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation
* Estimated glomerular filtration rate \<45 mL/min/1.73 m² (modification of diet in renal disease formula)
* Unstable angina pectoris
* Myocardial infarction within 6 months prior to randomization
* Planned surgery or cardiovascular intervention within 6 months after randomization
* Severe heart valve disease
* Severe comorbidities with limited life expectancy
* Pregnancy
* Participation in another trial

Answer: C