Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorProMedica Health System
About this trial
The study objective is to establish the safety and efficacy of endovascular adjunct stenting for patients undergoing mechanical thrombectomy (MT) that are found to have residual stenosis (70-99%) following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling.
Eligibility criteria
Qualifiers
18 to 80 years of age
Presenting with symptoms consistent with AIS
Imaging evidence of an anterior occlusion of the Internal Carotid Artery (ICA) or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND residual 70-99% stenosis of the index artery following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling
NIHSS ≥ 6
Disqualifiers
Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
Known severe allergy (more than a rash) to contrast media uncontrolled by medications.
Midline shift or herniation
Evidence of intracranial hemorrhage
Trial design
Treatments tested in this trial
- Mechanical Thrombectomy plus adjunct stenting
- Mechanical Thrombectomy
Treatment groups
342 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov