Stenting for Ischemic Strokes Secondary to Medically Refractory Intracranial Atherosclerotic Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNitin Goyal
About this trial
The goal of this observational study is to establish a prospective multicenter registry of patients undergoing intracranial stenting for ischemic strokes caused by medically refractory ICAD. The study aims to evaluate current practice patterns, periprocedural outcomes, and delayed outcomes.
Researchers will collect demographic and procedural data from patients who undergo intracranial stenting after having an ischemic stroke caused by medically refractory ICAD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients with ICAD resulting in 70-99% vessel stenosis who undergo PTAS with any device
Patients will have to experience a stroke despite medical management involving risk factor modification and an antiplatelet agent
Baseline modified Rankin Scale (mRS) ≤ 3
Performance of the endovascular procedure at least 3 days after the last stroke
Disqualifiers
Large vessel occlusion strokes undergoing rescue intracranial stenting will not be included
Baseline modified Rankin Scale (mRS) >3
Performance of the endovascular procedure less than 3 days after the last stroke.
Patients undergoing intracranial stenting for first stroke caused by ICAD
Trial population
The study population includes consecutive patients with ischemic strokes caused by medically refractory ICAD undergoing intracranial stenting.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Recurrent ischemic stroke within treated territory, ICH, or death
Recurrent ischemic stroke within the territory treated, intracranial hemorrhage, or death within 72 hours after the procedure. All of the patients enrolled in the trial will be assessed at 72 hours post-stenting either in the hospital by the study interventionalist or, if the patient had already been discharged home, by telephone interview by a core study nurse or interventionalist.
Time frame
72 hours post procedure2
Stroke, ICH, or neurological death in treated territory
Stroke within the territory treated, intracranial hemorrhage, or neurologic death within 6 months to 1 year after PTAS. All the patient enrolled in the trial will undergo * Follow up clinic visit between 6 months to 1 year per standard of care * Follow up vascular imaging (modality of imaging will be decided based on standard of care at participating centers)
Time frame
6 months to 1 year post procedureSecondary outcomes
1
Stent patency
Stent patency on follow up vascular imaging
Time frame
6 months to 1 year post procedure2
Re-stenosis ≥ 70%
Re-stenosis ≥ 70% on follow up vascular imaging
Time frame
6 months to 1 year post procedure3
mRS
mRS between days 180-360 after the procedure
Time frame
6 months to 1 year post procedure4
Mortality
Any death within 1 year after the procedure
Time frame
1 year post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: