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Trial registered on ANZCTR


Registration number
ACTRN12619001608156
Ethics application status
Approved
Date submitted
31/10/2019
Date registered
21/11/2019
Date last updated
15/08/2022
Date data sharing statement initially provided
21/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and Safety of the Extravascular Carotid Artery Pulse Modulation Device (The Pulse Modulation Study)
Scientific title
Feasibility and Safety of the Pulse Modulation Device in participants undergoing Surgery of the Common Carotid Artery (CCA) (The Pulse Modulation Study)
Secondary ID [1] 299616 0
Nil
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Pulse Pressure 314910 0
Alzheimer's disease 315206 0
Condition category
Condition code
Neurological 313264 313264 0 0
Alzheimer's disease
Surgery 313448 313448 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective, single arm feasibility study.

Participants already scheduled for Head and Neck surgery that involves exposure of the Common Carotid Artery (CCA) will be enrolled.

A small temporary cylindrical shaped device will be placed around the common carotid artery with the aim of modulating the characteristics of the arterial pulse. The surgeon will be responsible for placement. This modulation will be measured throughout the procedure by a ultrasound technician supporting the surgeon.

The intervention will be the temporary (up to 15 minute) unilateral placement of the device on one CCA during the course of the scheduled surgery. The application will occur mid procedure and observation will be made using tran cranial dopler imaging.
Intervention code [1] 315868 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321765 0
Feasibility:
The short term (15 minutes maximum) unilateral temporary application of theextravascular carotid pulse modulation device around the CCA followed by the device’s successful removal.
• Temporary arterial pulse wave modulation measured by TCD/TCCD on the ipsilateral MCA.
Timepoint [1] 321765 0
Intraoperatively while device is applied (15 minutes).
Primary outcome [2] 321919 0
Temporary arterial pulse wave modulation measured by TCD/TCCD on the ipsilateral MCA
Timepoint [2] 321919 0
Intraoperatively while device is applied (15 minutes).
Primary outcome [3] 321920 0
30-day rate of local hematoma (related to device application) as defined by the BARC scoring system
Timepoint [3] 321920 0
30 days post-surgery
Secondary outcome [1] 376140 0
Acute device success (application of pulse modulation device and its subsequent removal, with video and photos).
Timepoint [1] 376140 0
Intraoperatively while device is applied (15 minutes).
Secondary outcome [2] 376891 0
Procedural success (application and subsequent removal of pulse modulation device and determination of arterial pulse wave dampening parameters). Assessed by clinical opinion, photos, video recording, etc documented in source worksheets intraoperatively.
Timepoint [2] 376891 0
Intraoperatively while device is applied (15 minutes).

Eligibility
Key inclusion criteria
Particppant must be greater or equal to 21 years of age.
Particopant has the ability to understand and cooperate with study procedures and agrees to a post-operative (day 1) and 30 day follow-up visit, tests and exams.
Participants taking warfarin may be included if their dosage is reduced before the procedure per clinical surgical standard of care determined by the surgeon. Warfarin may be restarted to therapeutic dose following the procedure per standard of care.
The participant must sign a written informed consent prior to the procedure, using a form that is approved by the local ethics committee.
The life expectancy of the participant is at least six months.
The participant must have high pulse pressure, greater than or equal to 50mm Hg (brachial, standard technique).
The participant has an ipsilateral trans-temporal window for TCD. If the contralateral window is present, then contralateral MCA flow will be calculated intra operatively.
The participant must have a minimum distance of at least 5 cm disease free CCA (no protuberant plaque on pre-operative ultrasound) between the clavicle and CCA bifurcation.
Intra-operative determination by the surgeon that the CCA is suitable for pulse modulation device placement.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The participant is participating in another investigational trial that would interfere with the conduct or result of this study.
2. Female participants who are pregnant or may become pregnant.
3. The participant has dementia or a neurological illness at baseline that may confound the neurological evaluation.
4. The participant has known cardiac sources of emboli, for example (but not exclusively), left ventricular mural thrombus, prosthetic heart valves, left atrial myxoma.
5. The participant has documented chronic or paroxysmal atrial fibrillation within the prior 90 days.
6. Occlusion (TIMI 0 flow), or string sign of the ipsilateral CCA or internal carotid artery (ICA); see “Definitions”.
7. There is evidence of bilateral carotid stenosis that would require contralateral carotid CEA, in the case of a scheduled CEA, within 30 days of procedure.
8. There is a planned treatment of an ipsilateral non-target lesion from the arch origin to the distal ICA within 30 days post procedure.
9. Requirement for coronary artery bypass graft (CABG) or percutaneous valve (TAVR) within 30 days of ipsilateral neck surgery.
10. There is a history of intracranial haemorrhage within the past 3 months, including haemorrhagic transformation of an ischemic stroke.
11. The participant has an intracranial tumour.
12. There is evidence of a stroke within the prior 30 days of the procedure.
13. There is a history of an ipsilateral stroke with fluctuating neurologic symptoms within one year of the procedure.
14. There is a history of spontaneous intracranial haemorrhage <12 months previously, or recent stroke < 7 days, or stroke of sufficient volume to render revascularization at increased risk of reperfusion injury (hyper perfusion/haemorrhagic stroke): 1/3rd of the ipsilateral MCA volume.
15. Evolving stroke.
16. The participant has any medical criteria that would place them at higher than average risk of stroke/death during the neck procedure to include:
a. Congestive Cardiac Failure AHA Class III – IV (Index 2);
b. Unstable angina;
c. Recent MI <72 hours (see “Definitions”);
d. Severe COPD (see “Definitions”); or
e. Pro-coaguable state to include malignancies that pre-dispose to carotid artery /carotid arterial patch thrombosis; see Life Expectancy, Wallaert (12), (Index 3).
17. Presence of any one of the following anatomic risk factors:
a. Previous radiation treatment to the neck or radical neck dissection;
b. Tracheostomy or tracheal stoma;
c. Laryngectomy;
d. Contralateral laryngeal nerve palsy;
e. Inability to extend the head due to cervical arthritis or other cervical disorders;
f. High lesion (at or above the second cervical vertebra, C2, or above the angle of mandible);
g. Tandem lesions of the distal ICA or the distal CCA that require individual treatment beyond that of the target neck procedure; or
h. CEA restenosis.
18. There is an existing, previously placed stent in the ipsilateral CCA.
19. The participant has atherosclerotic disease, tortuosity or vessel depth involving the ipsilateral common carotid artery that precludes safe placement of the pulse modulating device (participants with CCA vessel depth to length ratio 1 or close to 1 shall be excluded).
20. The participant does not have a trans-temporal window on the ipsilateral side, as assessed on screening TCD/TCCD evaluation in advance of case scheduling (up to 10% of the population).
21. Intra-operative tests prior to pulse modulation device placement on the CCA:
a. Systolic blood pressure (BP) (per vital signs monitor) < 100mmHg.
22. Participant is scheduled for eversion CEA.
23. Participant has a known allergy to silicone or nitinol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a first in human pilot study there is no specific statistical design.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
9/12/2019
Actual
1/06/2020
Date of last participant enrolment
Anticipated
6/11/2020
Actual
30/12/2020
Date of last data collection
Anticipated
14/12/2020
Actual
Sample size
Target
15
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 15030 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 15031 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 22961 0
Strathfield Private Hospital - Strathfield
Recruitment hospital [4] 22962 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 28316 0
6009 - Nedlands
Recruitment postcode(s) [2] 28317 0
2050 - Camperdown
Recruitment postcode(s) [3] 38267 0
2135 - Strathfield
Recruitment postcode(s) [4] 38268 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 304093 0
Commercial sector/Industry
Name [1] 304093 0
Brain Protection Company
Country [1] 304093 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brain Protection Company
Address
52 Victoria Street Paddington NSW 2021
Country
Australia
Secondary sponsor category [1] 304302 0
None
Name [1] 304302 0
Address [1] 304302 0
Country [1] 304302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304582 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 304582 0
Ethics committee country [1] 304582 0
Australia
Date submitted for ethics approval [1] 304582 0
26/02/2019
Approval date [1] 304582 0
14/10/2019
Ethics approval number [1] 304582 0
RGS0000003136
Ethics committee name [2] 311441 0
Bellberry Ltd
Ethics committee address [2] 311441 0
Ethics committee country [2] 311441 0
Australia
Date submitted for ethics approval [2] 311441 0
30/03/2020
Approval date [2] 311441 0
28/04/2020
Ethics approval number [2] 311441 0
2020-03-296

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97470 0
A/Prof Associate Professor Shirley Jansen
Address 97470 0
Associate Professor Shirley Jansen
Sir Charles Gairdner Hospital
6th floor G block, Hospital Avenue
NEDLANDS Western Australia 6009
Country 97470 0
Australia
Phone 97470 0
+61 8 6151 0820
Fax 97470 0
Email 97470 0
Shirley.Jansen@health.wa.gov.au
Contact person for public queries
Name 97471 0
David Celermajer
Address 97471 0
The Brain Protection Company,
52 Victoria Street, Paddington, NSW 2021
Country 97471 0
Australia
Phone 97471 0
+61 407892271
Fax 97471 0
Email 97471 0
celermajer@bigpond.com
Contact person for scientific queries
Name 97472 0
David Celermajer
Address 97472 0
The Brain Protection Company
52 Victoria Street, Paddington, NSW 2021
Country 97472 0
Australia
Phone 97472 0
+61 407892217
Fax 97472 0
Email 97472 0
celermajer@bigpond.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.