BridgeMD
New treatment option for Stroke, Acute
Official title Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
ClinicalTrials.gov ID: NCT04261478
What this study is testing
What is Antiplatelet Agents?
Antiplatelet Agents is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stroke, acute.
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
- Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT). However, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc.
- 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
- Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous...
- 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
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
- Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis:
- 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's taking place
- 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 - 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?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.