HypertensionNCT02570113
The Peregrine Post-Market Study for the Treatment of Hypertension
A study testing Peregrine System Infusion Catheter in people with Hypertension, run by Ablative Solutions, Inc. at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- 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
- 45 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Nov 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 26Show fewer
- 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;
- Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract obstruction (with potential for hydronephrosis);
- Subject is known to have a non-functioning kidney or unequal renal size (>2 cm difference in renal length between kidneys associated with a chronic kidney disease or a deterioration of the kidney function);
- Subject has a renal transplant;
- Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within the last six months from planned procedure;
- Subject has hemodynamically significant valvular heart disease;
- Subject has heart failure (NYHA III or IV) or has an ejection fraction ≤30%;
- Subject with chronic atrial fibrillation;
- Subjects who are allergic or intolerant of the neurolytic agent (such as dehydrated alcohol);
- Any contraindication to the imaging as required per the protocol;
- Subject has a life expectancy of <12 months;
- 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.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany6 sites
Charite-Universitaetsmedizin Berlin
Berlin, 12203
Universitätsklinik Erlangen Klinik für Nephrologie/Hypertensiologie
Erlangen, 91054
Elisabeth-Krankenhause
Essen, 45138
CardioVasculares Centrum (CVC) Frankfurt
Frankfurt, 60389
Universitats-Herzzentrum/University Heart Center Klinik fur Kardiologie und Angiologie
Freiburg im Breisgau, 79106
Klinik fur Innere Medizin III
Homburg, 66421
Poland2 sites
Oddzial Kardiologii Inwazyjnej
Tychy, 43-100
Oddizal Kardiologiczno-Angiologiczny PAKS
Ustroń, 43-450
About this study
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
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.
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 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 use this agent.
- Conditions
- Hypertension
- Being tested
- Peregrine System Infusion Catheter
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peregrine System Infusion CatheterDevice
The Peregrine Catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Peregrine System Infusion Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Peri-procedural major vascular complications;
- Major Bleeding as defined by the TIMI Bleeding Classification;
- Acute Kidney Injury (AKI) within 1 month of the procedure
- Peri-procedural death (within 1 month of the procedure)
Measured: 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.
Measured: 6 months
Secondary outcomes (16)
Numbr of Subjects With a Decline in eGFR by >25% From Baseline to 6 Months
Proportion of subjects with a decline in eGFR by >25% from baseline to 6-month follow-up;
Measured: 6 months
Change in Serum Creatinine From Baseline to 6 Months
Change in serum creatinine from baseline to 6-month follow-up
Measured: 6 months
Number of Participants With New Renal Arterial Stenosis > 60%
Number of Participants with 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.
Measured: 6 months
Number of Subjects With Stroke or Transient Ischemic Attack (TIA) With 1 Month of the Procedure
Stroke or TIA within 1 month of the procedure
Measured: 1 month
Number of Subjects With Myocardial Infarction (MI) Within 1 Month of the Procedure
Myocardial Infarction (MI) within 1 month of the procedure
Measured: 1 month
Number of Participants With Major Adverse Events (MAE) Through 6 Months Post-Procedure
Number of Participants with Major Adverse Events (MAE) through 6-month post-procedure. MAE is defined as the occurrence of any of the following:
- All-cause death
- End stage renal failure
- Significant embolic event resulting in end-organ damage or requiring intervention to prevent it
- Major Vascular Complications (including major artery dissections)
- Significant new renal artery stenosis (>60% diameter stenosis)
- Hypertensive crisis (hypertensive emergency only)
- Severe hypotension/syncope
Measured: 6 months
Changes in Antihypertensive Medications at 7 Days, and 1, 3, 6 and 12 Months Post-Procedure
Changes in antihypertensive medications at 7-day, 1, 3, 6 and 12 months post procedure;
Measured: 7-day, 1, 3, 6 and 12 months
Changes in Systolic and Diastolic Clinic/Office Blood Pressure
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.
Measured: 7-day, 1, 3, 6 and 12 months
Changes in Systolic and Diastolic 24-hour Mean Daytime and Nighttime Ambulatory Blood Pressure
Changes in systolic and diastolic 24-hour mean daytime and nighttime ambulatory blood pressure, assessed at 1, 3, 6 and 12-month post-procedure.
Measured: 1, 3, 6 and 12-months
Changes in Diastolic 24-hour Mean Ambulatory Blood Pressure
Changes in systolic and diastolic 24-hour mean ambulatory blood pressure assessed at 1, 3, 6 and 12-month post-procedure.
Measured: 1, 3, 6 and 12-months
Changes in Systolic 24-hour Mean Ambulatory Blood Pressure
Changes in systolic 24-hour mean ambulatory blood pressure assessed at 1, 3 and 12 months postprocedure;
Measured: 1, 3 and 12 months
Change in eGFR
Change in eGFR from baseline, to evaluate the progression of Chronic Kidney Disease (CKD) after 1, 3, 6 and 12 months;
Measured: 1, 3, 6 and 12 months
The Progression of Kidney Disease
The progression of kidney disease in subjects with ≤60 mL/min/1.73m2 will be evaluated by comparing the change in eGFR during the study to the historical loss (reduction) of eGFR during the 3 years prior to renal denervation for each individual subject;
Measured: 1, 3, 6, and 12 months
Change in Albuminuria
Change in albuminuria from baseline to 3 months post-procedure, with additional assessments at each study time point;
Measured: 3, 6, and 12 months
Change in Albuminuria Categorization
Change in albuminuria categorization from baseline to 3 months post-procedure, with additional assessments at each study time point;
Measured: 3, 6, and 12 months
Change in Serum Creatinine and Cystatin-C
Change in serum creatinine and cystatin-C from baseline to 3 months postprocedure, with additional assessments at each study time point.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablative Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horst Sievert, MD, Principal investigator, CardioVasculares Centrum (CVC) Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570113
- Sponsor's protocol ID
- CR0001
- Status last verified
- Sep 2023
- First submitted
- 6 Oct 2015
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.
PubMed 39526682Mahfoud 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.
PubMed 34470501
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02570113
- Acronym / sponsor ID
- CR0001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ablative Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 use this agent.
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: Peregrine System Infusion CatheterInfusion 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (26 listed)
- Subject has a contraindication known for conventional percutaneous interventional procedures such as:
- 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;
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 |
|---|---|---|
| Peregrine System Infusion CatheterThe Peregrine 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
Number of Subjects With the Absence of Particular Events as Adjudicated by the CEC Through 1-month Post Procedure:
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)
Change in 24-hour Mean Ambulatory Systolic Blood Pressure From Baseline to 6 Months
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.
16 secondary outcomes
Numbr of Subjects With a Decline in eGFR by >25% From Baseline to 6 Months
Time frame: 6 months
Change in Serum Creatinine From Baseline to 6 Months
Time frame: 6 months
Number of Participants With New Renal Arterial Stenosis > 60%
Time frame: 6 months
Number of Subjects With Stroke or Transient Ischemic Attack (TIA) With 1 Month of the Procedure
Time frame: 1 month
Number of Subjects With Myocardial Infarction (MI) Within 1 Month of the Procedure
Time frame: 1 month
Number of Participants With Major Adverse Events (MAE) Through 6 Months Post-Procedure
Time frame: 6 months
Changes in Antihypertensive Medications at 7 Days, and 1, 3, 6 and 12 Months Post-Procedure
Time frame: 7-day, 1, 3, 6 and 12 months
Changes in Systolic and Diastolic Clinic/Office Blood Pressure
Time frame: 7-day, 1, 3, 6 and 12 months
Changes in Systolic and Diastolic 24-hour Mean Daytime and Nighttime Ambulatory Blood Pressure
Time frame: 1, 3, 6 and 12-months
Changes in Diastolic 24-hour Mean Ambulatory Blood Pressure
Time frame: 1, 3, 6 and 12-months
Changes in Systolic 24-hour Mean Ambulatory Blood Pressure
Time frame: 1, 3 and 12 months
Change in eGFR
Time frame: 1, 3, 6 and 12 months
The Progression of Kidney Disease
Time frame: 1, 3, 6, and 12 months
Change in Albuminuria
Time frame: 3, 6, and 12 months
Change in Albuminuria Categorization
Time frame: 3, 6, and 12 months
Change in Serum Creatinine and Cystatin-C
Time frame: 3, 6, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39526682Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.
- Derived from this study: PubMed 34470501Mahfoud 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.
- Individual participant dataSharing planned: No
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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.
Horst Sievert, MD principal investigator
CardioVasculares Centrum (CVC) Frankfurt
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peregrine System Infusion Catheter in people with Hypertension, run by Ablative Solutions, Inc. at 10 sites in 4 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 8 inclusion and 26 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Poland, Belgium, 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?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With the Absence of Particular Events as Adjudicated by the CEC Through 1-month Post Procedure: (time frame: 1-month). The study lists 2 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 NCT02570113, which also lists 2 linked publications.
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 28 Sep 2023.