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The Peregrine Post-Market Study for the Treatment of Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Ablative Solutions, Inc.
Sponsor:
Information provided by (Responsible Party):
Ablative Solutions, Inc.
ClinicalTrials.gov Identifier:
NCT02570113
First received: October 6, 2015
Last updated: March 16, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Hypertension
Device: Peregrine System Infusion Catheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Post-Market Study of Transcatheter Perivascular Renal Denervation for the Treatment of Hypertension Using the Ablative Solutions Inc. Peregrine System™ Infusion Catheter

Further study details as provided by Ablative Solutions, Inc.:

Primary Outcome Measures:
  • Number of Subjects with Treatment Related Adverse Events [ Time Frame: 1-month ]

    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)

  • Reduction of 24-hour Mean Ambulatory Systolic Blood Pressure [ Time Frame: 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.


Secondary Outcome Measures:
  • Proportion of subjects with a decline in eGFR by >25% [ Time Frame: 6 months ]
    Proportion of subjects with a decline in eGFR by >25% from baseline to 6-month follow-up;

  • Change in serum creatinine [ Time Frame: 6 months ]
    Change in serum creatinine from baseline to 6-month follow-up

  • New renal arterial stenosis > 60% [ Time Frame: 6 months ]
    New renal arterial stenosis > 60% from the baseline at the 6-month follow-up, to be confirmed by the same imaging method used at baseline.

  • Proportion of subjects with stroke or Transient Ischemic Attack (TIA) [ Time Frame: 1 month ]
    Stroke or TIA within 1 month of the procedure

  • Myocardial Infarction (MI) [ Time Frame: 1 month ]
    . Myocardial Infarction (MI) within 1 month of the procedure

  • Major Adverse Events (MAE) [ Time Frame: 6 months ]

    Major Adverse Events (MAE) through 6-month post-procedure. MAE is defined as the occurrence of any of the following:

    1. All-cause death
    2. End stage renal failure
    3. Significant embolic event resulting in end-organ damage or requiring intervention to prevent it
    4. Major Vascular Complications
    5. Significant new renal artery stenosis (>60% diameter stenosis)
    6. Hypertensive crisis
    7. Severe hypotension/syncope

  • Changes in antihypertensive medications [ Time Frame: 7-day, 1, 3, 6 and 12 months ]
    Changes in antihypertensive medications at 7-day, 1, 3, 6 and 12 months post procedure;

  • Changes in systolic and diastolic clinic/office blood pressure [ Time Frame: 7-day, 1, 3, 6 and 12 months ]
    Changes in systolic and diastolic clinic/office blood pressure following treatment compared to baseline, assessed at 7-day, 1, 3, 6 and 12 months post-procedure.

  • Changes in systolic and diastolic 24-hour mean daytime and nighttime ambulatory blood pressure [ Time Frame: 1, 3, 6 and 12-months ]
    Changes in systolic and diastolic 24-hour mean daytime and nighttime ambulatory blood pressure, assessed at 1, 3, 6 and 12-month post-procedure.

  • Changes in diastolic 24-hour mean ambulatory blood pressure [ Time Frame: 1, 3, 6 and 12-months ]
    Changes in systolic and diastolic 24-hour mean ambulatory blood pressure assessed at 1, 3, 6 and 12-month post-procedure.


Estimated Enrollment: 120
Study Start Date: November 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation by Neurolysis
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
The Peregrine Catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.

Detailed Description:

There is strong evidence in the published literature that the renal nerves are important contributors to hypertension, and that their ablation does not have adverse side-effects.

The literature provides technical, clinical and scientific evidence supporting the use of perivascular renal denervation for a carefully defined patient group.

An existing device (the Medtronic Symplicity catheter) was initially shown to be safe and effective for achieving perivascular renal denervation by delivery of radio-frequency energy. The results of early nonrandomized clinical studies (HTN-1, HTN-2) found that perivascular renal denervation by radio-frequency energy delivery was an effective therapy, associated with very low risks. In other contexts, denervation can also be safely and effectively achieved by neurolytic agents.

The ASI Peregrine System™ Infusion Catheter and the denervation procedure in general is similar enough to the Medtronic Symplicity catheter to enable the use of published data to establish the validity of the design concept of the Peregrine System and estimate the likely levels of risk of side effects. It can be concluded from the literature that the ASI Peregrine System™ will achieve percutaneous renal denervation with a low risk of procedural complications (comparable to accepted percutaneous interventional therapies) and without long-term impairment of renal artery or kidney function or other serious adverse events.

Previous premarket clinical trials have provided support for the safe and effective use of the Peregrine Catheter for the treatment of patients with hypertension. The Peregrine System Infusion Catheter is currently CE marked and the indication for use is "The Peregrine System™ Infusion Catheter is intended for the infusion of a neurolytic agent to achieve a reduction in systemic blood pressure in hypertensive patients." Based upon the literature and previous clinical data, chemical denervation is an appropriate treatment for the specified study population of adults who have hypertension despite taking at least 3 anti-hypertensive drugs of different classes including at least one diuretic.

The objectives of this post-market study are to collect additional safety and performance data pertaining to renal denervation by using dehydrated alcohol as a chemical neurolytic agent delivered into the adventitial/peri-adventitial area of the renal arteries for the purpose of renal denervation, using the Peregrine System™ Infusion Catheter, in patients with hypertension.

In order for the study to be valid, only one chemical neurolytic agent can be used. The Coordinating Investigator has chosen to use dehydrated alcohol (not less than 95% by volume) for therapeutic neurolysis, therefore all participating sites will usethis agent.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult subject, age 18-80, male or female;
  2. Subject has 3 measurements of office Systolic Blood Pressure with a mean of ≥ 150 mmHg.
  3. Subject has a 24-hour mean systolic Ambulatory Blood Pressure Measurement (ABPM) ≥ 135 mm Hg with ≥ 70% valid readings (as determined by measurement device);
  4. 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.
  5. 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.
  6. Subject has provided written informed consent.

Exclusion Criteria:

  1. Subject has a contraindication known for conventional percutaneous interventional procedures.
  2. Subject has known or suspected secondary hypertension;
  3. Subject has type 1 diabetes mellitus;
  4. Subject requires chronic oxygen support;
  5. Subject has primary or secondary pulmonary hypertension;
  6. Subject has a known bleeding diathesis. Subjects who are on anticoagulation therapy (vitamin K antagonist, factor Xa inhibitor or direct thrombin inhibitor) must be able to withhold medication before the procedure, on the advice of their Physician or the Investigator. For the decision and management of medication withdrawal, the Physician and Investigator should consider the ACCP Guidelines: Perioperative Management of Antithrombotic Therapy, 9th Edition;
  7. Subject has thrombocytopenia (platelet count <100,000 platelets/µL);
  8. Subject is pregnant or nursing or planning to become pregnant;
  9. Subject has an eGFR ≤ 45 mL/min, based on the CKD-EPI equation;
  10. Subject has imaging-assessed renal artery anatomy abnormalities or variations based on Investigator's evaluation of the screening images [i.e. MRA examination and/or renal angiography]) meeting one of the following criteria:

    • If either of the renal arteries (up to 2 on each side) has a diameter of <5 mm or >7 mm or a length of <11 mm each
    • Accessory renal arteries with diameter >2.0 mm and <5.0 mm
    • Renal artery stenosis >60% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment)
    • Aneurysm
    • Excessive tortuosity
    • Moderate or severe renal artery calcification
    • Previous stenting or balloon angioplasty of the renal arteries
    • Previous renal denervation;
  11. Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract obstruction (with potential for hydronephrosis);
  12. Subject is known to have a unilateral non-functioning kidney or unequal renal size (>2 cm difference in renal length between kidneys);
  13. Subject has a renal transplant;
  14. Subject has a history of heterogeneities in the kidney such as cysts or tumors (however patients with simple renal cysts may be enrolled if the nephrologist/hypertensionist and Investigator determine the cyst(s) to be clinically insignificant);
  15. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within the last six months;
  16. Subject has hemodynamically significant valvular heart disease;
  17. Subject has heart failure (NYHA III or IV) or has an ejection fraction ≤ 30%;
  18. Subject has an implanted cardioverter defibrillator (ICD), pacemaker or neurostimulator or any metallic implant which is not compatible with magnetic resonance imaging. NOTE: If a subject is not eligible for MRA, but is otherwise eligible for the study, the Investigator may choose to perform contrast angiography using fluoroscopy to make the final determination of anatomic eligibility;
  19. Subject has a known allergy to contrast media which cannot be managed medically
  20. Subject has a life expectancy of <12 months;
  21. Subject is currently enrolled in other potentially confounding research, i.e., another therapeutic or interventional research trial. Subjects enrolled in observational registries may still be eligible.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02570113

Contacts
Contact: Horst Sievert, MD 0049 46031340 horstsievertmed@aol.com
Contact: Ali Kakavand, PhD +1 650 575 5534 akakavand@ablativesolutions.com

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Alexandre Persu, MD PhD    +32 2 764 25 33      
Czech Republic
Na Homolce Hospital Active, not recruiting
Prague, Czech Republic, 150 30
Germany
Charite-Universitaetsmedizin Berlin Recruiting
Berlin, Germany, 12203
Contact: Maximilian de Bucourt, MD    0049 304 5062 7085      
Universitätsklinik Erlangen Klinik für Nephrologie/Hypertensiologie Recruiting
Erlangen, Germany, 91054
Contact: Roland E Schmieder, Prof. Dr. med.    +49 9131 85 36245      
Elisabeth-Krankenhaus Essen GmbH Recruiting
Essen, Germany, 45138
Contact: Thomas Schmitz, MD    +49 201 897 3200      
CardioVasculares Centrum (CVC) Frankfurt Recruiting
Frankfurt, Germany, 60389
Contact: Horst Sievert, MD    0049 46031340      
Universitats-Herzzentrum/University Heart Center Klinik fur Kardiologie und Angiologie Recruiting
Freiburg, Germany, 79106
Contact: Andreas Zirlik, MD    0049 76127034415      
Klinik fur Innere Medizin III Recruiting
Homburg, Germany, 66421
Contact: Felix Mahfoud, MD PhD    +49 6841 16 15911      
Poland
Oddzial Kardiologii Inwazyjnej Active, not recruiting
Tychy, Poland, 43-100
Oddizal Kardiologiczno-Angiologiczny PAKS Active, not recruiting
Ustron, Poland, 43-450
Sponsors and Collaborators
Ablative Solutions, Inc.
Investigators
Principal Investigator: Horst Sievert, MD CardioVasculares Centrum (CVC) Frankfurt
  More Information

Responsible Party: Ablative Solutions, Inc.
ClinicalTrials.gov Identifier: NCT02570113     History of Changes
Other Study ID Numbers: CR0001
Study First Received: October 6, 2015
Last Updated: March 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 28, 2017