REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study /

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Uncontrolled Stage 2 Hypertension.

Sponsors

Lead Sponsor: SoniVie Inc.

Source SoniVie Inc.
Brief Summary

This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.

Overall Status Not yet recruiting
Start Date 2022-07-01
Completion Date 2025-12-01
Primary Completion Date 2023-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety 1 month
Safety 12 month
Effectiveness 3 months
Secondary Outcome
Measure Time Frame
Effectiveness 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 3, 6, 12, 24, 36 months
Effectiveness 6, 12 months
Effectiveness 3, 6, 12 months
Effectiveness 3, 6, 12 months
Effectiveness 3, 6, 12 months
Effectiveness 6, 12 months
Effectiveness 3, 6, 12 months
Enrollment 25
Condition
Intervention

Intervention Type: Device

Intervention Name: Renal denervation

Description: The TIVUS system will be used for renal denervation

Eligibility

Criteria:

Inclusion Criteria: 1. Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure. 2. Individual has office systolic blood pressure (SBP) ≥ 140 mm Hg but < 180 mm Hg, and a diastolic blood pressure (DBP) ≥ 90 mm Hg but < 110 mm Hg based on an average of 3 office blood pressure readings measured by a manual, automated or semi-automated validated BP monitor, on current medications. 3. Documented 24-hour ABPM systolic blood pressure (SBP) ≥ 135 mm Hg but < 180 mm Hg, and diastolic blood pressure (DBP) ≥80 mm Hg during daytime and nighttime measures within 4 weeks of the Screening II visit. 4. Patient is either on at least one anti-hypertensive medication at maximal tolerated dose with a medically documented intolerance to one or more medications, or on three medications including a diuretic. 5. Patient is willing and expected to maintain their anti-hypertensive medication regimen for at least 3 months. 6. Patient is able and willing to comply with all study procedures. Exclusion Criteria: 1. Patient has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as single kidney, other renal development anomaly such as ectopic or horseshoe kidney, or polycystic kidney disease precluding renal denervation therapy as detailed in the angiographic exclusion criteria. 2. Patient with renal artery diameter < 4mm. 3. Patient with fibromuscular dysplasia. 4. Patient with > 30% stenosis in the target vessel. 5. Pregnant or breastfeeding women or women planning a pregnancy within 12 months of study enrollment. 6. Patient has an estimated glomerular filtration rate (eGFR) of < 40mL/min/1.73m2 CKD-EPI. 7. Patients with uncontrolled rapid AF. 8. Patient had a previous renal denervation procedure. 9. Pulse pressure defined as office (systolic pressure - diastolic pressure) > 60 mm Hg 10. Isolated systolic hypertension (ISH) defined as office systolic pressure > 140 with diastolic < 90 mm Hg. 11. Patients with 24-hour ABPM systolic blood pressure (SBP) > 170 mm Hg. 12. Patient has type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 9%). 13. Patient has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques. 14. Patient has a planned major surgery or cardiovascular intervention in the next 6 months. 15. Patient undergone a major surgery or cardiovascular intervention in the previous 3 months. 16. Patient 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. 17. Patient taking Immunosuppressive therapy. 18. Patient on anticoagulant therapy that cannot be temporarily withheld for study procedure. 19. Contraindication to recommended denervation procedure medications or intravascular contrast that cannot be adequately controlled with pre-medication. 20. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints. For patient previously participating in a drug trial, allow a wash-off period of at least of 5 half-lives of the investigational drug. 21. Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry. 22. Patient works the night shift. 23. A history of prior renal artery angioplasty or stenting. 24. Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram. 25. Aortic or Mitral valvular stenosis with risk of cardiac event with significant and/or abrupt decline in systolic blood pressure. 26. Untreated secondary cause of hypertension. 27. Device therapy within the past five years for the treatment of hypertension. 28. Prior renal stent. 29. Life expectancy <1 year. 30. Active renal transplant or planned renal transplantation within the next year. 31. History of one or more episodes of severe orthostatic hypotension within the past year. 32. Patient has unstable cardiac or pulmonary disease (including pulmonary hypertension) requiring chronic oxygen support. 33. Uncontrolled or inadequately treated bleeding diathesis.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2022-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym REDUCED
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Intervention Model Description: Prospective, multicenter, non-randomized, open-label clinical study

Primary Purpose: Treatment

Masking: None (Open Label)

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