Ablative Solutions, Inc.
To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter in hypertensive subjects in the absence of antihypertensive medications.
This Phase 3, prospective, randomized, blinded, sham procedure-controlled, multicenter study will assess the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Catheter in hypertensive subjects in the absence of antihypertensive medications. Subjects with a documented history of uncontrolled hypertension who are taking 0, 1, or 2 antihypertensive medications at enrollment will be recruited. After providing written informed consent, subjects will undergo screening assessments to assess eligibility for the study. Eligible subjects will then enter a run-in…
Inclusion Criteria: 1. Has 2 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg. 2. Documented history of uncontrolled hypertension and is currently taking 0, 1, or 2 antihypertensive medications. 3. Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure). 4. Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings. Exclusion Criteria: 1. Has renal artery an…
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
Endovascular, renal angiography
Arctuva estimate
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