The Peregrine Study: A Safety and Performance Study of Renal Denervation

NCT02155790 | Completed DMC

• 1 other identifier: ASI 12-001
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 3

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 typically 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 resistant hypertension - seriously elevated blood pressure which does not respond to drug treatment.

Conditions

Hypertension

Keywords

safety, performance, hypertension, renal denervation

Outcome Measures

Primary Outcomes (6)

• Vessel dissection or perforation

  Vessel dissection or perforation on immediate post-procedural fluoroscopy

  Immediate post procedure

• Grade 3 or Grade 4 hemorrhage

  Grade 3 hemorrhage requiring transfusion or Grade 4 hemorrhage

  During or immediately after procedure

• Cerebrovascular accident

  Cerebrovascular accident at the time of procedure

  Time of procedure

• Myocardial infarction

  Myocardial infarction at the time of the procedure

  Time of procedure

• Sudden cardiac death

  Sudden cardiac death at the time of the procedure

  Time of procedure

• Reduction in the systolic blood pressure

  The primary performance endpoint is a reduction in the clinic systolicand diastolic blood pressure following treatment compared to baseline, assessed at 6 months.

  6 months

Secondary Outcomes (6)

• Change in eGFR (reduction >25%)

  baseline to 6 months

• New renal arterial stenosis >60%

  6 months

• Mean change in serum creatinine

  post baseline visits at 7d,1 mo,3mo,6mo,12mo,24mo

• Adverse events

  post baseline visits at 7d,1 mo,3mo,6mo,12mo,24moprocedure and each of the follow-up time periods

• Changes in antihypertensive medications

  post baseline visits at 7d,1 mo,3mo,6mo,12mo,24moeach of the follow-up visits

Study Arms (1)

Renal Denervation by Neurolysis

EXPERIMENTAL

Infusion of 0.3 ml of dehydrated alcohol (96%-98%) 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: The Peregrine System Infusion Catheter

Interventions

The Peregrine System Infusion Catheter DEVICE

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

Also known as: Renal denervation using a neurolytic agent

Renal Denervation by Neurolysis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, age 18-75, male or female;
• 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;
• Patient has a daytime mean systolic pressure ≥135 mm Hg based on 24 hours ambulatory blood pressure monitoring, with \>85% valid readings.
• Patient with resistant hypertension is receiving and adhering to a stable medication regimen of at least 3 anti-hypertensive medications of different classes (for at least 4 weeks), one of which must be a diuretic. The three (or more) - medication regimen must be maximal in terms of dose and tolerability in the judgement of the investigator, such that the next step in blood pressure management would be the addition of a further medication.
• Patient has an eGFR ≥ 45 mL/min, based on the CKD-EPI equation;
• Patient has no implanted ICD, pacemaker or neurostimulator or any metallic implant which is not compatible with magnetic resonance imaging. THis is applicable to sites were MRI is planned. Implanted devices are acceptable at sites where CT will be used
• Patient has optimal renal artery anatomy (no clear abnormalities) based on Investigator's evaluation of CT-angiogram/ or as alternative MR-angiogram and /or renal angiogram including:
• Single or two renal arteries, if each has a 5-7 mm diameter, respectively (accessory renal arteries are acceptable if diameter is is ≤ 2 mm, which will not be treated)
• No aneurysms
• No excessive tortuosity
• No previous stenting or balloon angioplasty of the renal arteries
• No previous renal denervation;
• Patient has provided written informed consent

You may not qualify if:

• Patient has known or suspected secondary hypertension;
• Patient has type 1 diabetes mellitus;
• Patient requires chronic oxygen support;
• Patient has primary or secondary pulmonary hypertension;
• Patient has a known bleeding diathesis.
• Patient has thrombocytopenia (platelet count \<100,000 platelets/µL;
• Patient is pregnant or nursing or planning to become pregant;
• Patient has significant imaging-assessed renovascular abnormalities including short length main renal artery (\< 10mm) and renal artery stenosis \>60% of the normal diameter segment;
• Patient has history of nephrectomy, a single kidney, kidney tumor or urinary tract obstruction (with potential for hydronephrosis);
• Patient is known to have a unilateral non-functioning kidney or unequal renal size (\>2 cm difference in renal length between kidneys);
• Patient has a renal transplant;
• Patient has a history of kidney stones;
• Patient has a history of heterogeneities in the kidney such as cysts or tumors;
• Patient has a history of pyelonephritis;
• Patient has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months;

Sponsors & Collaborators

• Ablative Solutions, Inc.: lead

Study Sites (3)

Na Homolce Hospital

Prague, 15030, Czechia

Location

American Heart of Poland

Tychy, Poland

Location

American Heart of Poland

Ustroń, 43-450, Poland

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wojciech Wojakowski, Prof.MD.PhD

  American Hospitals Poland

  PRINCIPAL INVESTIGATOR

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: May 27, 2014
• First Posted: June 4, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: September 4, 2017
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

PL (2); CZ (1)