Treatment of resistant hypertension using a radiofrequency percutaneous transluminal angioplasty Catheter (POST MARKET APPROVAL SURVEILLANCE STUDY)

Phase 4

Completed

• Conditions: Therapy resistant hypertension; 10057166

• Registration Number: NL-OMON39303
• Lead Sponsor: Vessix Vascular, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Subjects who have provided written informed consent;
2. Subjects who are * 18 years and * 75 years of age;
3. Subjects who have SBP & DBP * 160/90 mm Hg based on an average of three (3) office-based blood pressure readings (seated) measured according to protocol;
4. Subjects on a stable medication regimen with * 3 anti-hypertensive drugs (one 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;
5. Subjects with a eGFR * 45 ml/min per 1.73m²;
6. Subjects who are willing and able to comply with all study procedures.;Anatomical Inclusion Criteria:
1. Subjects, with or without an accessory renal artery, with a main renal artery diameter of * 3.5 mm and * 7.0 mm for each of their kidneys.
2. Subject with a main renal artery without significant stenosis (stenosis defined as < 30%).
3. Subjects with a renal artery length of * 15 mm.

Exclusion Criteria

1. Subjects with secondary hypertension;
2. Subjects who are contraindicated for intravascular contrast material;
3. Subjects who 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;
4. Subjects with known bleeding or hyper-coagulation disorders;
5. Subjects who have type 1 diabetes mellitus;
6. Subjects who 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;
7. Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next 6 months;
8. Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous;
9. Subjects who have an implantable cardioverter defibrillator (ICD) or pacemaker or
abnormal electrocardiogram at time of screening;
10. Subjects who have any serious medical condition, which in the opinion of the investigator, may adversely affect patient safety or the efficacy of the procedure in the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders);
11. Subjects who 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);
12. Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;
13. Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed;
14. Subjects who, for any reason, may not be able to understand or comply with instructions; ;Anatomical Exclusion Criteria:
1. Subjects with only one kidney;
2. Subjects with prior renal denervation procedure;
3. Subjects with prior intervention to right or left renal artery;
4. Subjects with renal artery stenosis as defined by * 30% stenosis confirmed by angiography with two (2) orthogonal views with selective catheterization;
5. Subjects with iliac stenosis requiring intervention at time of procedure and/or within the next six (6) months;
6. Subjects with severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure;
7. Subjects in which the physician is unable to cannulate the renal artery;
8. Subjects in which the physician is unable to access the femoral artery by percutaneous means.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Efficacy Endpoint<br /><br>1. Reduction of systolic and diastolic blood pressure at six (6) months as<br /><br>measured by office-based blood pressure assessment (seated) following<br /><br>therapeutic renal denervation compared to baseline according to a standardized<br /><br>procedure using a validated electronic device (Omron model HEM-705 CP which<br /><br>includes a printer attachment).<br /><br>2. Reduction of systolic and diastolic blood pressure at six (6) months as<br /><br>measured by 24-hour ambulatory blood pressure monitoring following therapeutic<br /><br>renal denervation compared to baseline using a validated ABPM device.</p><br>