At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 350 enrolled
Drug / intervention
Alcohol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications
In Brief
A Phase 2 clinical trial evaluating Alcohol and Sham control for Hypertension and Hypertension,Essential. Completed, enrolled 350 participants across 4 sites in 4 countries.
Detailed Summary
To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Hypertension,Essential
CountriesBelgium, France, Germany, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartSep 2018
Primary CompletionJan 2022
Study CompletionJan 2024
TodayJul 2026
First PostedApr 20, 2018
Enrollment StartSep 24, 2018
Primary CompletionJan 31, 2022
Study CompletionJan 10, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.2 years ago
Interventions
Alcoholdrug
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
Sham controlother
endovascular, renal angiography