Recruiting PHASE3 Stroke, Acute

New treatment option for Stroke, Acute

Official title Carotid Artery Stenting During Endovascular Treatment of Acute Stroke

ClinicalTrials.gov ID: NCT06511089

What this study is testing

What it's testing
Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. It is uncertain whether immediate carotid artery stenting (CAS) of a cervical carotid artery stenosis during endovascular thrombectomy (EVT) is beneficial.
  • Phase 3: a large, late-stage study
  • 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 stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography
  • Stenosis \>50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin...
  • Eligible for EVT according to the guidelines: EVT within 6 hours of onset or EVT between 6-24 hours after onset based on perfusion CT imaging...
  • Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2
  • Age \>18 years

You likely can't join if

  • Any intracranial hemorrhage
  • Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus...
  • Any exclusion criterion for EVT according to the guidelines
  • Pre stroke disability (defined as a modified Rankin Scale score \>2)
  • Recent gastro-intestinal or urinary tract hemorrhage (\<6 weeks)
  • Recent severe head trauma (\<6 weeks)
See the full eligibility criteria
Who can join
  • Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography
  • Stenosis \>50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography
  • Eligible for EVT according to the guidelines: EVT within 6 hours of onset or EVT between 6-24 hours after onset based on perfusion CT imaging selection (conform current guidelines)
  • Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2
  • Age \>18 years
  • Written informed consent (deferred consent)
What rules you out
  • Any intracranial hemorrhage
  • Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)
  • Any exclusion criterion for EVT according to the guidelines
  • Pre stroke disability (defined as a modified Rankin Scale score \>2)
  • Recent gastro-intestinal or urinary tract hemorrhage (\<6 weeks)
  • Recent severe head trauma (\<6 weeks)
  • Recent infarction on baseline brain CT in the same vascular territory (\<6 weeks)
  • Known allergy to aspirin and/or clopidogrel
  • Pregnancy

The study team makes the final eligibility decision.

Where it's taking place

  • Groningen, Netherlands

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 Groningen, Netherlands. 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.