We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Target BP OFF-MED
Previous Study | Return to List | Next Study


The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03503773
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : June 9, 2022
Information provided by (Responsible Party):
Ablative Solutions, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Hypertension,Essential Drug: Alcohol Other: Sham control Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subjects who continue to be eligible at the end of the run-in period will be randomized in a 1:1 ratio to one of the following 2 groups via central randomization (stratified by study site):

  • Treatment Arm: renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
  • Sham Control Arm: only renal angiography performed
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Blinded (The subject, sponsor, and hypertensionist/nephrologist performing the screening and follow-up assessments are blinded. The interventionalist and cath lab staff are unblinded.)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 24, 2018
Actual Primary Completion Date : January 31, 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Arm:
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Drug: Alcohol
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

Sham Comparator: Sham Control Arm
Only renal angiography performed
Other: Sham control
endovascular, renal angiography

Primary Outcome Measures :
  1. Changes in Systolic Ambulatory Blood Pressure [ Time Frame: Baseline to 8 weeks post-treatment ]
    Change in mean 24-hour ambulatory SBP

Secondary Outcome Measures :
  1. Changes in Ambulatory Blood Pressure [ Time Frame: Baseline, and 8 weeks, 6 months, 12 months post treatment ]
    Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP

  2. Changes in Office Blood Pressure [ Time Frame: Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment ]
    Change in mean office SBP and DBP

  3. Use of antihypertensive medication(s) [ Time Frame: 8 weeks, 6 months,1 year post treatment ]
    Evaluate differences between groups

  4. Evaluation of safety [ Time Frame: 30 days post procedure ]
    Major adverse events (MAEs)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥140 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
  2. Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
  3. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

Exclusion Criteria:

  1. Subject has renal artery anatomy abnormalities.
  2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
  3. Subject has documented sleep apnea.
  4. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
  5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
  6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
  7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503773

Layout table for location information
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Clinique Pasteur Toulouse
Toulouse, France
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
United Kingdom
NIHR Barts Cardiovascular Biomedical Research Unit
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Ablative Solutions, Inc.
Layout table for investigator information
Principal Investigator: Felix Mahfoud, Prof.Dr.med. Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin, Germany
Principal Investigator: Atul Pathak, Prof. Clinique Pasteur Hi-LAB, Toulouse, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ablative Solutions, Inc.
ClinicalTrials.gov Identifier: NCT03503773    
Other Study ID Numbers: CR0014
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ablative Solutions, Inc.:
Renal Denervation
Additional relevant MeSH terms:
Layout table for MeSH terms
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases