Clinical trial NCT04987710: Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes
Official title: Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Thromboembolic Stroke
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of rescue intracranial stenting is thought to be associated with better outcomes than with patients received medical treatment only after failed thrombectomy as Reperfusion technique. This raised the questions about the factors that affect outcomes of rescue intracranial stenting angioplasty, so the best outcomes can be achieved.

Detailed description: Mechanical Thrombectomy is the first line therapy in acute ischemic stroke due to large vessel occlusion. Recently, there is an increasing number of patients with failed re perfusion after mechanical thrombectomy, due to preexisting high degree of intracranial stenosis or failed mechanical thrombectomy. This is associated with poor clinical and functional outcome for the patients.

The percentage of patients with failed mechanical thrombectomy is as high as 40-45% of all patients with ischemic stroke due to large vessel occlusion.

This group is in need for rescue intracranial stenting to achieve re-canalization of the occluded vessel and restore perfusion.

The results demonstrated superiority of medical management over stenting with less complications and this had almost put the intracranial stenting to rest for years.

The main complication related to rescue stenting are ischemic complications especially thromboembolic events related to thrombus detachment, symptomatic intracerebral hemorrhage and re-stenosis of cerebral arteries after stenting.

Recently, the results of the Chinese Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis trial and the Wingspan Stent System Post Market Surveillance Study (WEAVE trial) showed that most of complications are related to peri-procedural techniques. This raise the interest again in the efficacy of intracranial stenting as treatment modality for selected patients.

The use of rescue intracranial stenting is thought to be associated with better outcomes than with patients received medical treatment only after failed thrombectomy as Reperfusion technique. This raised the questions about the factors that affect outcomes of rescue intracranial stenting angioplasty, so the best outcomes can be achieved.

Eligibility criteria: Inclusion Criteria:

1. Patients with acute ischemic stroke due to large vessel occlusion as confirmed by CT angiography or Magnetic resonance (MR) angiography.
2. Baseline NIHSS \>6.
3. Presenting within the first 6 hours from onset of symptoms.
4. First ever stroke or pre-stroke modified Rankin Score (mRS) ≤1.

Exclusion Criteria:

1. Patients with intra cranial hemorrhage.
2. Patients younger than 18 years.
3. Patients with acute ischemic stroke due to small vessel disease or vasculitis.
4. Patients with acute ischemic stroke due to occlusion of vessels of posterior circulation.
5. Patients who refused to be included in the study.
6. Patients with contraindications to intracranial stent placement (as total occlusion of artery).

Primary outcomes:
measure: number of participants with good re-perfusion after successful rescue stenting
timeFrame: 12 months
Secondary outcomes:
measure: Compare the clinical outcomes of participants with rescue stenting with those who received medical treatment.
timeFrame: 12 months
measure: Compare the radio-logical outcomes of participants with rescue stenting with those who received medical treatment.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
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