THRIVE

THRIVE
Enrolling By Invitation
22 years - 75 years
All
Phase N/A
1 Location

Brief description of study

THRIVE is an international, multicenter, 2:1 randomized, double blind, sham-controlled study, designed to demonstrate the adjunctive effectiveness and safety of the Therapeutic Intravascular Ultrasound (TIVUS) Renal Denervation System in hypertensive subjects while subjects are maintained off-antihypertensive medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after procedure.

Detailed description of study

The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in:

  1. subjects with hypertension (HTN) receiving up to 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure.
  2. subjects with controlled hypertension receiving up to 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hypertension
  • Age: 22 years - 75 years
  • Gender: All

Inclusion

  1. Documented history of hypertension
  2. Previously or currently prescribed antihypertensive therapy

  3. Subject has an office BP (average of 3 seated measurements) of:

    1. Uncontrolled BP: ≥ 140/90 mmHg <180/110 mmHg at Screening Visit (V0) while stable for at least 4 weeks on 0-2 anti-hypertensive medications of different classes* and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure, or,
    2. Controlled BP: < 140/90 mmHg while stable for at least 4 weeks on 1-2 antihypertensive medications of different classes and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure

Exclusion

  1. Subject has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy
  2. Uncorrected causes of secondary hypertension other than sleep apnea
  3. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥ 9.0%)
  4. Cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 6 months prior to consent
  5. History of severe cardiovascular event (e.g. myocardial infarction, unstable angina, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 12 months prior to consent

Updated on 02 Apr 2026. Study ID: 25-0987
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