HypertensionNCT02155790

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

A study testing The Peregrine System Infusion Catheter in people with Hypertension, run by Ablative Solutions, Inc. at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension
What is being tested?: The Peregrine System Infusion Catheter
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 3 sitesin 2 countries
Study dates: Jul 2014to 4 Sep 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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;

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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;
Patient has hemodynamically significant valvular heart disease;
Patient has heart failure (NYHA III or IV) or has an ejection fraction ≤ 30%;
Patient has a known allergy to contrast media;
Patient has a life expectancy of <12 months;
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.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Poland2 sites

American Heart of Poland
Tychy
American Heart of Poland
Ustroń, 43-450

Other trials in Poland

Czechia1 site

Na Homolce Hospital
Prague, 15030

Other trials in Czechia

About this study

Official title: A Safety and Performance Study of Renal Denervation by Neurolysis Using the Ablative Solutions Inc. Peregrine System™ Infusion Catheter

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.

Read the 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 (96 - 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.

Conditions: Hypertension
Being tested: The Peregrine System Infusion Catheter
Keywords: safety, performance, hypertension, renal denervation
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Peregrine System Infusion CatheterDevice
Also called Renal denervation using a neurolytic agent
The ASI catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.

Study groups in NCT02155790
Study group	Role	What they receive
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. Receives: Device: The Peregrine System Infusion Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Vessel dissection or perforation
Vessel dissection or perforation on immediate post-procedural fluoroscopy
Measured: Immediate post procedure
Grade 3 or Grade 4 hemorrhage
Grade 3 hemorrhage requiring transfusion or Grade 4 hemorrhage
Measured: During or immediately after procedure
Cerebrovascular accident
Cerebrovascular accident at the time of procedure
Measured: Time of procedure
Myocardial infarction
Myocardial infarction at the time of the procedure
Measured: Time of procedure
Sudden cardiac death
Sudden cardiac death at the time of the procedure
Measured: 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.
Measured: 6 months

Secondary outcomes (6)

Change in eGFR (reduction >25%)
Proportion of patients with a decline in eGFR by >25% from baseline to 6 months follow-up
Measured: baseline to 6 months
New renal arterial stenosis >60%
New renal arterial stenosis >60% from baseline confirmed by the same method used at baseline
Measured: 6 months
Mean change in serum creatinine
Change in serum creatinine
Measured: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24mo
Adverse events
Adverse events - device and non-device related
Measured: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24moprocedure and each of the follow-up time periods
Changes in antihypertensive medications
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.
Measured: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24moeach of the follow-up visits
Changes in ambulatory blood pressure measurements
Ambulatory blood pressures will be reported to determine if they follow a similar patter to the clinic blood pressures.
Measured: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24mo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20144 Sep 2017

First posted4 Jun 2014 (estimated)
Study startJul 2014
Primary completionJan 2016
Study completion4 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02155790
Sponsor's protocol ID: ASI 12-001
Status last verified: Jun 2018
First submitted: 27 May 2014
Last updated: 14 Jun 2018
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Performance Study of Renal Denervation by Neurolysis Using the Ablative Solutions Inc. Peregrine System™ Infusion Catheter
ClinicalTrials.gov ID: NCT02155790
Acronym / sponsor ID: ASI 12-001
Conditions: Hypertension
Keywords: safety, performance, hypertension, renal denervation
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Ablative Solutions, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Jan 2016 (actual)
Study completion: 4 Sep 2017 (actual)
First posted: 4 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Renal Denervation by Neurolysis	Experimental	Device: The Peregrine System Infusion CatheterInfusion 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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;

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Peregrine System Infusion CatheterAlso: Renal denervation using a neurolytic agentThe ASI catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.	Device	Renal Denervation by Neurolysis

Primary outcome

Vessel dissection or perforation
Time frame: Immediate post procedure
Vessel dissection or perforation on immediate post-procedural fluoroscopy
Grade 3 or Grade 4 hemorrhage
Time frame: During or immediately after procedure
Grade 3 hemorrhage requiring transfusion or Grade 4 hemorrhage
Cerebrovascular accident
Time frame: Time of procedure
Cerebrovascular accident at the time of procedure
Myocardial infarction
Time frame: Time of procedure
Myocardial infarction at the time of the procedure
Sudden cardiac death
Time frame: Time of procedure
Sudden cardiac death at the time of the procedure
Reduction in the systolic blood pressure
Time frame: 6 months
The primary performance endpoint is a reduction in the clinic systolicand diastolic blood pressure following treatment compared to baseline, assessed at 6 months.

6 secondary outcomes

Change in eGFR (reduction >25%)
Time frame: baseline to 6 months
New renal arterial stenosis >60%
Time frame: 6 months
Mean change in serum creatinine
Time frame: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24mo
Adverse events
Time frame: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24moprocedure and each of the follow-up time periods
Changes in antihypertensive medications
Time frame: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24moeach of the follow-up visits
Changes in ambulatory blood pressure measurements
Time frame: post baseline visits at 7d,1 mo,3mo,6mo,12mo,24mo

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wojciech Wojakowski, Prof.MD.PhD principal investigator

American Hospitals Poland

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Peregrine System Infusion Catheter in people with Hypertension, run by Ablative Solutions, Inc. at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vessel dissection or perforation (time frame: Immediate post procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02155790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.