None listed
Conditions
Brief summary
The purpose of this research is to explore the early safety and feasibility of a device that might eventually be useful in delaying progression of Alzheimer’s Disease.
Interventions
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.
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.
Sponsors
Brain Protection Company
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed