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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03503773
Other study ID # CR0014
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 24, 2018
Est. completion date December 2023

Study information

Verified date July 2023
Source Ablative Solutions, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date December 2023
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Drug:
Alcohol
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
Other:
Sham control
endovascular, renal angiography

Locations

Country Name City State
Belgium Cliniques Universitaires Saint-Luc Brussels
France Clinique Pasteur Toulouse Toulouse
Germany Universitätsklinikum des Saarlandes Homburg/Saar
United Kingdom NIHR Barts Cardiovascular Biomedical Research Unit London

Sponsors (1)

Lead Sponsor Collaborator
Ablative Solutions, Inc.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Systolic Ambulatory Blood Pressure Change in mean 24-hour ambulatory SBP Baseline to 8 weeks post-treatment
Secondary Changes in Ambulatory Blood Pressure Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP Baseline, and 8 weeks, 6 months, 12 months post treatment
Secondary Changes in Office Blood Pressure Change in mean office SBP and DBP Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment
Secondary Use of antihypertensive medication(s) Evaluate differences between groups 8 weeks, 6 months,1 year post treatment
Secondary Evaluation of safety Major adverse events (MAEs) 30 days post procedure
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