Trial Outcomes & Findings for The Peregrine Post-Market Study for the Treatment of Hypertension (NCT NCT02570113)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

1-month

Results posted on

2023-09-28

Participant Flow

Withdrawal of consent (N=3)

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	45
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Renal Denervation by Neurolysis n=45 Participants 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. 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.
Age, Continuous	55 years STANDARD_DEVIATION 10 • n=45 Participants
Sex: Female, Male Female	17 Participants n=45 Participants
Sex: Female, Male Male	28 Participants n=45 Participants
Region of Enrollment Europe	45 Participants n=45 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Renal Denervation by Neurolysis n=45 Participants 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. 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.
Number of Subjects With the Absence of Particular Events as Adjudicated by the CEC Through 1-month Post Procedure:	43 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Renal Denervation by Neurolysis n=42 Participants 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. 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.
Change in 24-hour Mean Ambulatory Systolic Blood Pressure From Baseline to 6 Months	-11 mmHg Standard Deviation 14

SECONDARY outcome

Timeframe: 6 months

Proportion of subjects with a decline in eGFR by \>25% from baseline to 6-month follow-up;

Outcome measures

Outcome measures
Measure	Renal Denervation by Neurolysis n=44 Participants 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. 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.
Numbr of Subjects With a Decline in eGFR by >25% From Baseline to 6 Months	2 Participants

SECONDARY outcome

Timeframe: 6 months

Change in serum creatinine from baseline to 6-month follow-up

Outcome measures

Outcome measures
Measure	Renal Denervation by Neurolysis n=44 Participants 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. 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.
Change in Serum Creatinine From Baseline to 6 Months	0.01 mg/dL Standard Deviation 0.13

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Renal Denervation by Neurolysis n=44 Participants 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. 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.
Number of Participants With New Renal Arterial Stenosis > 60%	0 Participants

SECONDARY outcome

Timeframe: 1 month

Stroke or TIA within 1 month of the procedure

Outcome measures

Outcome measures
Measure	Renal Denervation by Neurolysis n=45 Participants 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. 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.
Number of Subjects With Stroke or Transient Ischemic Attack (TIA) With 1 Month of the Procedure	0 Participants

SECONDARY outcome

Timeframe: 1 month

Myocardial Infarction (MI) within 1 month of the procedure

Outcome measures

Outcome measures
Measure	Renal Denervation by Neurolysis n=45 Participants 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. 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.
Number of Subjects With Myocardial Infarction (MI) Within 1 Month of the Procedure	0 Participants

SECONDARY outcome

Timeframe: 6 months

Number of Participants with 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 (including major artery dissections) 5. Significant new renal artery stenosis (\>60% diameter stenosis) 6. Hypertensive crisis (hypertensive emergency only) 7. Severe hypotension/syncope

Outcome measures

Outcome measures
Measure	Renal Denervation by Neurolysis n=44 Participants 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. 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.
Number of Participants With Major Adverse Events (MAE) Through 6 Months Post-Procedure	3 Participants

SECONDARY outcome

Timeframe: 7-day, 1, 3, 6 and 12 months

Changes in antihypertensive medications at 7-day, 1, 3, 6 and 12 months post procedure;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3 and 12 months

Changes in systolic 24-hour mean ambulatory blood pressure assessed at 1, 3 and 12 months postprocedure;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3, 6 and 12 months

Change in eGFR from baseline, to evaluate the progression of Chronic Kidney Disease (CKD) after 1, 3, 6 and 12 months;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

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;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6, and 12 months

Change in albuminuria from baseline to 3 months post-procedure, with additional assessments at each study time point;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6, and 12 months

Change in albuminuria categorization from baseline to 3 months post-procedure, with additional assessments at each study time point;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6, and 12 months

Change in serum creatinine and cystatin-C from baseline to 3 months postprocedure, with additional assessments at each study time point.

Outcome measures

Outcome data not reported

Adverse Events

Renal Denervation by Neurolysis

Serious events: 11 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Renal Denervation by Neurolysis n=45 participants at risk 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. 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.
Vascular disorders haematoma	2.2% 1/45 • Number of events 1 • 6 months
Vascular disorders Haemorrhage	2.2% 1/45 • Number of events 1 • 6 months
Vascular disorders Peripheral artery stenosis	2.2% 1/45 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Subdural haematoma	2.2% 1/45 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Vascular pseudoaneurysm	2.2% 1/45 • Number of events 1 • 6 months
Renal and urinary disorders Nephrolithiasis	2.2% 1/45 • Number of events 1 • 6 months
Renal and urinary disorders Renal colic	2.2% 1/45 • Number of events 1 • 6 months
Cardiac disorders Arrhythmia	2.2% 1/45 • Number of events 1 • 6 months
Cardiac disorders Coronary artery disease	2.2% 1/45 • Number of events 1 • 6 months
Gastrointestinal disorders Abdominal pain	2.2% 1/45 • Number of events 1 • 6 months
Gastrointestinal disorders Food poisoning	2.2% 1/45 • Number of events 1 • 6 months
Infections and infestations Vascular access site infection	2.2% 1/45 • Number of events 1 • 6 months
Investigations Psychiatric evaluation	2.2% 1/45 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Osteoarthritis	2.2% 1/45 • Number of events 1 • 6 months
Eye disorders Vitreous hemorrhage	2.2% 1/45 • Number of events 1 • 6 months
Nervous system disorders Cerebrovascular accident	2.2% 1/45 • Number of events 1 • 6 months
Surgical and medical procedures Ureteral stent removal	2.2% 1/45 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	Renal Denervation by Neurolysis n=45 participants at risk 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. 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.
Vascular disorders hematoma	26.7% 12/45 • 6 months
Musculoskeletal and connective tissue disorders back pain	24.4% 11/45 • 6 months
Ear and labyrinth disorders vertigo	11.1% 5/45 • 6 months
Infections and infestations upper respiratory tract infection	8.9% 4/45 • 6 months
Nervous system disorders headache	8.9% 4/45 • 6 months
Cardiac disorders bradycardia	8.9% 4/45 • 6 months
Gastrointestinal disorders nausea	6.7% 3/45 • 6 months
Musculoskeletal and connective tissue disorders musculoskeletal pain	6.7% 3/45 • 6 months
Cardiac disorders arrhythmia	6.7% 3/45 • 6 months
Infections and infestations nasopharyngitis	6.7% 3/45 • 6 months
Vascular disorders vascular pseudoaneurysm	6.7% 3/45 • 6 months

Additional Information

Kate Rumrill

Ablative Solutions Inc

Phone: +1 (650) 688-9743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place