Carotid Stenosis Management During COVID-19 Era - Pilot Study

Launched by ZEALAND UNIVERSITY HOSPITAL · Jun 30, 2021

Keywords

ClinConnect Summary

The "Carotid Stenosis Management During COVID-19 Era - Pilot Study" is a clinical trial looking at how well patients with carotid stenosis (narrowing of the arteries in the neck) can be managed with medical treatment alone during the COVID-19 pandemic. Traditionally, patients might have undergone procedures like carotid endarterectomy (CEA) or carotid stenting (CAS) to treat this condition, but the pandemic has made these procedures less accessible. This study aims to see if patients receiving the best medical care alone can have fewer strokes and complications than those in previous studies who underwent surgery.

To be eligible for the trial, patients must generally be over 80 years old, have a life expectancy of more than three years, and have specific types of carotid artery narrowing (between 50-99%). They should also have had a recent non-disabling stroke or temporary stroke-like symptoms. Participants can expect close monitoring and care, with the goal of ensuring their health and safety during this challenging time. If you or a loved one meet these criteria and are interested, this trial could provide an important opportunity to help manage carotid stenosis during the pandemic.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who's life expectancy is \> 3 years despite age \> 80 years.
• • Patients who have not been timely offered CEA under COVID-19 (eg women / men with 50-69%), which can only be operated on after 4 weeks after their last symptom.
• • Patients with modified ranking scale (mRs) \> 3, which during rehabilitation improve and move to mRs \< 3.
• • High risk cardio pulmonary patients (ejection fraction \< 20% - severe chronic obstructive pulmonary disease) that is not estimated to withstand surgery or has a technically demanding neck anatomy with a life expectancy \> 3 years.
• • Patients who score below 15% on Carotid Artery Risk score (CAR-score) (5-year stroke risk is \< 15% with only best medical treatment) for ipsilateral stroke.
• • Patients with newly discovered cancer and stroke who require a cancer disease investigation or treatment and have a life expectancy of more than 3 years.
• • 50-69% and 70-99% narrowing (stenosis) of the ipsilateral internal carotid artery origin (and/or carotid bulb) verified by duplex ultrasound, CT-angio or MR-angio.
• • Presence of an ipsilateral non-disabling (non-severe) stroke (mRs \< 3, ie mRs of 1 or 2) or transient ischaemic attack (TIA) in the previous four (1,2) to six months (1,3) and ipsilateral 50-99% carotid stenosis measured using NASCET criteria.
• • Index symptoms attributable to atherosclerotic carotid disease (not due to fibromuscular dysplasia, aneurysm or tumour).
• • Absence of severe stroke on either side resulting in no useful function in the affected arterial territory
• • Absence of a known more severe ipsilateral intracranial infarct site of arterial narrowing
• • Absence of previous ipsilateral CEA or angioplasty/stenting or other carotid revascularisation procedure.
• • Mentally competent and consenting to participate in CASCOM Pilot Study in minimum 3 years.
• • Life expectancy \> 3 years including the absence of kidney, liver or lung failure or advanced cancer or advanced dementia, major/severe stroke (mRs \> 3), perceived significant frailty or unsuitable arterial anatomy. Risk classification level of IV or higher as well as CAR-score.
• • Absence of cardiac valvular or rhythm disorder likely associated with cardioembolism. In the absence of more specific published information the investigators will exclude patients with newly discovered atrial fibrillation and prosthetic heart valves from the primary analyses of symptomatic patients.
• • Exclusion Criteria
• • Progressive neurological dysfunction and major Stoke mRs \> 3 without remission after 4 weeks from their last symptom.
• • Advanced cancer patients with survivals \< 3 years.
• • Newly Myocardia infarction within previous 6 months.
• • Stroke or TIA in connection with surgical procedure, heart surgery, neuro surgery or other major surgery.
• • Stroke and TIA due to Carotid dissection.
• • Stroke and TIA as urgently treated by EVT (endovascular trombendarterectomy)
• • Unstable angina, or myocardial infarction within previous 6 months, or progressive neurological dysfunction or major surgery within the previous 30 days.