Brief Summary
SUMMIT RISE Study of Acute Ischemic Stroke Patients
Brief Title
SUMMIT RISE Study of Acute Ischemic Stroke Patients
Detailed Description
SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
650-581-1179
Central Contact Email
reneek@r92m.com
Completion Date
Completion Date Type
Estimated
Conditions
ACUTE ISCHEMIC STROKE
Eligibility Criteria
Inclusion Criteria:
* Acute ischemic stroke patient initially treated (first pass) with a Route 92 Medical Reperfusion System
* Informed consent completed and documented within 72 hours following thrombectomy procedure
* Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
* Age ≥ 18 years
Exclusion Criteria:
* None
* Acute ischemic stroke patient initially treated (first pass) with a Route 92 Medical Reperfusion System
* Informed consent completed and documented within 72 hours following thrombectomy procedure
* Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
* Age ≥ 18 years
Exclusion Criteria:
* None
Inclusion Criteria
Inclusion Criteria:
* Acute ischemic stroke patient initially treated (first pass) with a Route 92 Medical Reperfusion System
* Informed consent completed and documented within 72 hours following thrombectomy procedure
* Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
* Age ≥ 18 years
* Acute ischemic stroke patient initially treated (first pass) with a Route 92 Medical Reperfusion System
* Informed consent completed and documented within 72 hours following thrombectomy procedure
* Endovascular treatment initiated (defined as time of groin puncture) within 8 hours from time last known well
* Age ≥ 18 years
Gender
All
Gender Based
false
Keywords
Acute Ischemic Stroke
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07436156
Org Class
Industry
Org Full Name
Route 92 Medical, Inc.
Org Study Id
CIP 4262
Overall Status
Recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
SUMMIT RISE Study of Acute Ischemic Stroke Patients Evaluating the Route 92 Medical Reperfusion Systems.
Primary Outcomes
Outcome Description
Revascularization status checklist
Outcome Measure
Periprocedural eTICI measurement of revascularization
Outcome Time Frame
Periprocedural
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Richard Zampolin
Investigator Email
rzampoli@montefiore.org
Investigator Phone
rzampoli
Investigator Department
Radiology
Investigator Division
Neuroradiology
Investigator Sponsor Organization
Montefiore
Study Department
Radiology
Study Division
Neuroradiology
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- ISCHEMIC STROKE
Brain, Spinal Cord & Nervous System --- STROKE
Brain, Spinal Cord & Nervous System --- CEREBROVASCULAR DISORDERS
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
ISCHEMIC STROKE
STROKE
CEREBROVASCULAR DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
VASCULAR DISEASES
CARDIOVASCULAR DISEASES