The Peregrine Post-Market Study for the Treatment of Hypertension

NCT02570113 | Completed Results DMC

• 1 other identifier: CR0001
• Study Type: interventional
• Target: 45
• Locations: 4 countries
• Sites: 10

Brief Summary

The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device which is intended to be used to ablate the afferent and efferent sympathetic nerves serving the kidneys. The catheter is inserted via the femoral artery, steered into the renal artery, and then delivers, by infusion from its distal end, a neurolytic agent. This targets the nerve bundles, which are in the adventitia - a sheath surrounding the artery. The aim is to reduce blood pressure in cases of hypertension, including seriously elevated blood pressure which does not respond to drug treatment. This study will evaluate the safety and performance of the device.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With the Absence of Particular Events as Adjudicated by the CEC Through 1-month Post Procedure:

  The primary safety endpoint is defined by the absence of any of the following events as adjudicated by the CEC through 1-month post procedure: 1. Peri-procedural major vascular complications; 2. Major Bleeding as defined by the TIMI Bleeding Classification; 3. Acute Kidney Injury (AKI) within 1 month of the procedure 4. Peri-procedural death (within 1 month of the procedure)

  1-month

• Change in 24-hour Mean Ambulatory Systolic Blood Pressure From Baseline to 6 Months

  The primary performance endpoint is defined as a reduction of 24-hour mean ambulatory systolic blood pressure following treatment at 6 months, as compared to baseline.

  6 months

Secondary Outcomes (16)

• Numbr of Subjects With a Decline in eGFR by >25% From Baseline to 6 Months

  6 months

• Change in Serum Creatinine From Baseline to 6 Months

  6 months

• Number of Participants With New Renal Arterial Stenosis > 60%

  6 months

• Number of Subjects With Stroke or Transient Ischemic Attack (TIA) With 1 Month of the Procedure

  1 month

• Number of Subjects With Myocardial Infarction (MI) Within 1 Month of the Procedure

  1 month

Study Arms (1)

Renal Denervation by Neurolysis

EXPERIMENTAL

Infusion of 0.6 ml of dehydrated alcohol (not less than 95% by volume) into the peri-adventitial space of the renal artery, to achieve renal denervation by neurolysis, via three simultaneous deployed needles, situated at the distal end of the Peregrine System Infusion Catheter.

Device: Peregrine System Infusion Catheter

Interventions

Peregrine System Infusion Catheter DEVICE

The Peregrine Catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.

Renal Denervation by Neurolysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subject, age 18-80, male or female;
• Subject has a target treatment vasculature diameter of ≥4 mm and ≤ 7 mm and length of ≥5 mm;
• Subject has 3 measurements with a mean of office Systolic Blood Pressure of
• ≥150 mmHg AND office Diastolic Blood Pressure of ≥85 mmHg;
• Subject has a 24-hour mean systolic Ambulatory Blood Pressure Measurement (ABPM) ≥135 mm Hg with ≥70% valid readings (as determined by measurement device);
• Subject with hypertension is receiving and adhering to a stable medication regimen of at least 3 anti-hypertensive medications of different classes (for at least 4 consecutive weeks), one of which must be a diuretic;
• Subject agrees to have all study procedures performed, to comply with medication regimen and is able and willing to comply with all study follow-up visits;
• Subject has provided written informed consent.

You may not qualify if:

• Subject has a contraindication known for conventional percutaneous interventional procedures such as:
• intolerance for antiplatelet/anticoagulant therapy
• known allergy to contrast media
• bleeding disorders (such as bleeding diathesis, thrombocytopenia and severe anemia)
• Subject has documented severe untreated obstructive sleep apnea (Apnea Hypopnea Index \[AHI\] ≥30 per hour);
• Subjects with nephrotic syndrome;
• Subjects on immunosuppressive medications or immunosuppressive doses of steroids;
• Subject has type 1 diabetes mellitus;
• Subject is pregnant or nursing or planning to become pregnant;
• Subject has an eGFR ≤20 mL/min/1.73m2
• , based on the CKD-EPI equation;
• Subject has imaging-assessed renal artery anatomy abnormalities or variations based on Investigator's evaluation of the screening images \[i.e. MRA/CTA examination and/or renal angiography\]) meeting one of the following criteria:
• Renal artery stenosis \>60% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment);
• Any renal artery abnormality or disease that, per the physician assessment, precludes the safe insertion of the guiding catheter (such as but not limited to severe renal artery aneurysm, excessive tortuosity, severe renal artery calcification);
• Previous renal angioplasty associated with stenting or other implants, that, per the physician's assessment, precludes the safe deployment of the Peregrine catheter components in the target treatment segment of the renal artery;

Sponsors & Collaborators

• Ablative Solutions, Inc.: lead

Study Sites (10)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Na Homolce Hospital

Prague, 150 30, Czechia

Location

Charite-Universitaetsmedizin Berlin

Berlin, 12203, Germany

Location

Universitätsklinik Erlangen Klinik für Nephrologie/Hypertensiologie

Erlangen, 91054, Germany

Location

Elisabeth-Krankenhause

Essen, 45138, Germany

Location

CardioVasculares Centrum (CVC) Frankfurt

Frankfurt, 60389, Germany

Location

Universitats-Herzzentrum/University Heart Center Klinik fur Kardiologie und Angiologie

Freiburg im Breisgau, 79106, Germany

Location

Klinik fur Innere Medizin III

Homburg, 66421, Germany

Location

Oddzial Kardiologii Inwazyjnej

Tychy, 43-100, Poland

Location

Oddizal Kardiologiczno-Angiologiczny PAKS

Ustroń, 43-450, Poland

Location

Related Publications (1)

• Mahfoud F, Sievert H, Bertog S, Lauder L, Ewen S, Lengele JP, Wojakowski W, Schmieder R, van der Giet M, Weber MA, Kandzari DE, Parise H, Fischell TA, Pathak A, Persu A. Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension. Circ Cardiovasc Interv. 2021 Sep;14(9):e010075. doi: 10.1161/CIRCINTERVENTIONS.120.010075. Epub 2021 Sep 2.

  PMID: 34470501 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kate Rumrill
• Organization: Ablative Solutions Inc

krumrill@ablativesolutions.com

+1 (650) 688-9743

Study Officials

• Horst Sievert, MD

  CardioVasculares Centrum (CVC) Frankfurt

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 7, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); DE (6); BE (1); PL (2)