A Safety and Performance Study of Renal Denervation by Neurolysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ablative Solutions, Inc.
Sponsor:
Information provided by (Responsible Party):
Ablative Solutions, Inc.
ClinicalTrials.gov Identifier:
NCT02155790
First received: May 27, 2014
Last updated: September 2, 2014
Last verified: September 2014
  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 typically inserted via the femoral artery, steered into the renal artery, and then delivers, by injection 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 resistant hypertension - seriously elevated blood pressure which does not respond to drug treatment.


Condition Intervention Phase
Hypertension
Device: The Ablative Solutions Peregrine Infusion Catheter
Device: Injection of a neurolytic agent for denervation of the renal sympathetic nerves
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety and Performance Study of Renal Denervation by Neurolysis Using the Ablative Solutions Inc.Peregrine System™ Infusion Catheter; "The Peregrine Study"

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Vessel dissection or perforation [ Time Frame: Immediate post procedure ] [ Designated as safety issue: Yes ]
    Vessel dissection or perforation on immediate post-procedural fluoroscopy

  • Grade 3 or Grade 4 hemorrhage [ Time Frame: During or immediately after procedure ] [ Designated as safety issue: Yes ]
    Grade 3 hemorrhage requiring transfusion or Grade 4 hemorrhage

  • Cerebrovascular accident [ Time Frame: Time of procedure ] [ Designated as safety issue: Yes ]
    Cerebrovascular accident at the time of procedure

  • Myocardial infarction [ Time Frame: Time of procedure ] [ Designated as safety issue: Yes ]
    Myocardial infarction at the time of the procedure

  • Sudden cardiac death [ Time Frame: Time of procedure ] [ Designated as safety issue: Yes ]
    Sudden cardiac death at the time of the procedure

  • Reduction in the systolic blood pressure of at least 10% [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary performance endpoint is a reduction in the systolic blood pressure of at least 10%. This reduction should correspond to approximately 20 mm Hg less than the baseline value.


Secondary Outcome Measures:
  • Change in eGFR (reduction >25%) [ Time Frame: Two serial measurements at 6 months ] [ Designated as safety issue: Yes ]
    Change in eGFR (reduction >25% confirmed by at least 2 serial measurements at 6 months)

  • New renal arterial stenosis >60% [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    New renal arterial stenosis >60% confirmed by CT angiogram at 6 months

  • Change in serum creatinine [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Change in serum creatinine

  • Adverse events [ Time Frame: During procedure and at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    Adverse events - device and non-device related

  • Changes in antihypertensive medications [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

    The addition of new antihypertensive drugs will be considered an intensification of the antihypertensive regimen.

    Discontinuation of one or more of the baseline antihypertensive medications without an increase in dose of remaining drugs or addition of new drugs will be considered a reduction in antihypertensive drug regimen.


  • Changes in ambulatory blood pressure measurements [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Ambulatory blood pressures will be reported to determine if they follow a similar patter to the clinic blood pressures.


Estimated Enrollment: 20
Study Start Date: July 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-randomized Device: The Ablative Solutions Peregrine Infusion Catheter
The ASI catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.
Other Name: Renal denervation using a neurolytic agent
Device: Injection of a neurolytic agent for denervation of the renal sympathetic nerves

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 Ardian Symplicity catheter) has been shown to be safe and effective for achieving perivascular renal denervation by delivery of radiofrequency energy. Perivascular renal denervation by radio-frequency energy delivery is an effective therapy, associated with very low risks. In other contexts, denervation can also be safely and effectively achieved by neurolytic agents.

The objectives of the study are to evaluate the safety and performance of renal denervation by a chemical neurolytic agent delivered into the advential/ periadventitial area of the renal arteries for the purpose of neurolysis, using the Peregrine System Infusion Catheter, in patients with refractory hypertension.

The ASI Peregrine System Infusion Catheter is similar enough to the Ardian 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 from 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.

Chemical denervation is an appropriate treatment for the specified study population of adults who have resistant hypertension despite taking at least 3 anti-hypertensive drugs of different classes including at least one diuretic. 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 98% by volume) for therapeutic neurolysis, therefore all participating sites will use this agent. This clinical investigation is intended to provide clinical data that demonstrates the safety and performance of the ASI Peregrine System Infusion Catheter.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patient, age 18-75, male or female;
  2. Patient has a clinic systolic blood pressure ≥ 160 mm Hg (or ≥ 150 mm Hg in type 2 diabetic patients) based on an average of 3 office/clinic measurements taken manually;
  3. Patient has a daytime mean systolic pressure ≥135 mm Hg based on 24 hours ambulatory blood pressure monitoring;
  4. Patient is receiving a stable medication regimen of at least 3 antihypertensive medications of different classes (for at least 4 weeks), one of which must be a diuretic, and the medication regimen is not expected to change for at least 1 month;
  5. Patient has an eGFR ≥ 45 mL/min, based on the CKD-EPI equation;
  6. Patient has optimal renal artery anatomy (no clear abnormalities) based on Investigator's evaluation of CT examination and/or angiogram including:

    • Single artery of 5-7 mm in diameter (two arteries are acceptable if diameter of second artery is ≤ 2 mm)
    • No aneurysms
    • No excessive tortuosity
    • No previous stenting or balloon angioplasty of the renal arteries.
  7. Patient has provided written informed consent

Exclusion Criteria:

  1. Patient has known or suspected secondary hypertension;
  2. Patient has type 1 diabetes mellitus;
  3. Patient requires chronic oxygen support;
  4. Patient has primary or secondary pulmonary hypertension;
  5. Patient has a known bleeding diathesis or is receiving anticoagulant drugs during the 7 days prior to treatment;
  6. Patient has thrombocytopenia (platelet count <100,000 platelets/µL;
  7. Patient is pregnant or nursing;
  8. Patient has significant imaging-assessed renovascular abnormalities including short length main renal artery and renal artery stenosis >70% of the normal diameter segment;
  9. Patient has history of nephrectomy, kidney tumor or hydronephrosis;
  10. Patient is known to have a unilateral non-functioning kidney or unequal renal size (>2 cm difference in renal length between kidneys);
  11. Patient has a renal transplant;
  12. Patient has a history of kidney stones;
  13. Patient has a history of heterogeneities in the kidney such as cysts or tumors;
  14. Patient has a history of pyelonephritis;
  15. Patient has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months;
  16. Patient has hemodynamically significant valvular heart disease;
  17. Patient has heart failure (NYHA III or IV) or has an ejection fraction ≤ 30%;
  18. Patient has a known allergy to contrast media;
  19. Patient has a life expectancy of <12 months;
  20. Patient is currently enrolled in other potentially confounding research, i.e., another therapeutic or interventional research trial. Patients 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: NCT02155790

Contacts
Contact: Wojtek Wojakowski, M.D. +48 (604) 188 669 wojtek.wojakowski@gmail.com
Contact: Krzysztof Milewski, M.D. +48 (609) 109 131 k.milewski@ahp-ccrd.org

Locations
Poland
American Heart of Poland Recruiting
Tychy, Poland
American Heart of Poland Recruiting
Ustron, Poland
Contact: Wojtek Wojakowski, M.D.    +48 604 188 669    wojtek.wojakowski@gmail.com   
Principal Investigator: Mariusz Hochul, M.D.         
Sponsors and Collaborators
Ablative Solutions, Inc.
Investigators
Principal Investigator: Wojtek Wojakowski, M.D. American Hospitals Poland
  More Information

No publications provided

Responsible Party: Ablative Solutions, Inc.
ClinicalTrials.gov Identifier: NCT02155790     History of Changes
Other Study ID Numbers: ASI 12-001
Study First Received: May 27, 2014
Last Updated: September 2, 2014
Health Authority: Office for Registration of Medicinal Products, Medical Devices and Biocides: Poland

Keywords provided by Ablative Solutions, Inc.:
safety, performance, hypertension, renal denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014