Stroke, Acute study: Carotid artery stenting vs Antiplatelet Agents
Official title Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
ClinicalTrials.gov ID: NCT04261478
What this study is testing
What is Antiplatelet Agents?
An investigational antiplatelet regimen being studied as a potential treatment for acute stroke after endovascular thrombectomy. is designed to inhibit platelet aggregation and reduce clot formation.
Also referred to as Aspirin, Clopidogrel.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether placing a stent in the neck artery during clot‑removal surgery leads to better function after 90 days compared to clot removal alone.
- Who it's for
- Adults who have an acute stroke caused by a clot in the front part of the brain and also have a severe narrowing or blockage of the same side neck artery.
- What's involved
- Participants will be randomly assigned to receive either a stent placed in the neck artery during the clot‑removal procedure or to have the clot‑removal alone. They will have standard hospital care, imaging tests, and follow‑up visits.
- Time commitment
- The trial lasts about three months, with the main procedure done during the emergency hospital stay and follow‑up visits up to 90 days after the stroke.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA)
- A neurological deficit judged to be disabling by the patient and/or treating physician
- Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT
- Groin puncture within 24-hours of onset or last known normal
- Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial...
You likely can't join if
- Pre-existing neurological impairment (modified Rankin score ≥3)
- Any underlying disease or condition making protocol adherence and/or 3-month follow-up unlikely
- Any known contra-indication to EVT, angioplasty/stenting, or antiplatelet therapy
- Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography
- Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection
- Isolated cervical carotid occlusion without intracranial occlusion
See the full eligibility criteria
- Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA)
- A neurological deficit judged to be disabling by the patient and/or treating physician
- Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT
- Groin puncture within 24-hours of onset or last known normal
- Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging
- Informed consent from patient or surrogate or deferral of consent, according to local ethics policies
- Pre-existing neurological impairment (modified Rankin score ≥3)
- Any underlying disease or condition making protocol adherence and/or 3-month follow-up unlikely
- Any known contra-indication to EVT, angioplasty/stenting, or antiplatelet therapy
- Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography
- Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection
- Isolated cervical carotid occlusion without intracranial occlusion
- Pregnancy
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.