RECRUITING

Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A phase III, randomized, multi-center, investigational, open label clinical trial that will examine whether treatment with endovascular thrombectomy is superior to standard medical therapy alone in patients who suffer a Distal Medium Vessel Occlusion Ischemic Stroke within 12 hours from time last seen well

Official Title

A Phase III, Randomized, Multicenter, Investigational, Open Label Clinical Trial That Will Examine Whether Treatment With Endovascular Thrombectomy is Superior to Standard Medical Therapy Alone in Patients Who Suffer a Distal Medium Vessel Occlusion Ischemic Strokes.

Quick Facts

Study Start:2024-04-02

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05983757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥18 years (no upper age limit) 2. Acute ischemic stroke where patient is ineligible for or has failed\* IV thrombolytic treatment and is ineligible for endovascular treatment under best guideline-based care due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1 and co-dominant or dominant M2\\ segments, and vertebrobasilar arteries).\\\* 3. Evidence of a primary (e.g. not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) resulting in significant clinical deficits and expected to be treatable by endovascular thrombectomy. Regardless of vessel anatomic location, all vessel diameters should be within 1.5mm -2.5mm. (refer to the device labeling for recommended vessel diameters for each device model.)\* 4. No significant pre-stroke functional disability (mRS ≤2) 5. Evidence of a disabling stroke defined as follows: 1. Baseline National Institutes of Health Stroke Scale (NIHSS) score \>5 at the time of randomization. 2. NIHSS 3-5 with disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis/ loss of hand or leg function as established by the treating team in context of the patient's life. 6. The presence of a Target Mismatch defined as: 1. Ischemic Core \< 50cc (defined on NCCT/CTP\* or DWI-MRI) 2. Mismatch Volume (TMax \>6sec lesion - Core volume lesion) \>10cc 3. Mismatch Ratio \>1.4 7. Patient treatable within 12 hours of symptom onset. Symptoms onset is defined as the point in time the patient was last seen well (at baseline). Treatment start is defined as the time of arterial puncture. 8. Informed consent obtained from patient or acceptable patient surrogate	1. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH). 2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having no residual disabling deficits and an NIHSS score of \<5 at randomization. 3. Significant ischemic changes in a territory other than the occluded site that in the opinion of the investigator could reduce the benefit of endovascular treatment. 4. Contra indication to imaging with MR or CT with contrast agents. 5. Infarct core \>1/3 occluded territory (MCA, ACA, or PCA) qualitatively or \>50 mL quantitatively (determined by NCCT, CTP or DWI). 6. Any terminal illness such that patient would not be expected to survive more than 1 year. 7. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma. 8. Any imaging findings suggestive of futile recanalization in the judgment of the local investigator. 9. Premorbid disability (mRS ≥3). 10. Inability to initiate endovascular treatment within 12 hours of last seen well. 11. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS. 12. Baseline blood glucose of \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol). 13. Known history of hereditary or acquired hemorrhagic diathesis and/or platelet count \<100,000/uL. 14. Known renal failure as defined as serum creatinine levels \> 3.0 mg/dL. 15. Presumed septic embolus or suspicion of bacterial endocarditis. 16. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. 17. History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 18. Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation) 19. Subject participating in a study involving an investigational drug or device that would impact this study 20. Known pregnancy 21. Prisoner or incarceration 22. Known acute symptomatic COVID-19 infection

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years (no upper age limit)
2. Acute ischemic stroke where patient is ineligible for or has failed\* IV thrombolytic treatment and is ineligible for endovascular treatment under best guideline-based care due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1 and co-dominant or dominant M2\*\* segments, and vertebrobasilar arteries).\*\*\*
3. Evidence of a primary (e.g. not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) resulting in significant clinical deficits and expected to be treatable by endovascular thrombectomy. Regardless of vessel anatomic location, all vessel diameters should be within 1.5mm -2.5mm. (refer to the device labeling for recommended vessel diameters for each device model.)\*
4. No significant pre-stroke functional disability (mRS ≤2)
5. Evidence of a disabling stroke defined as follows:
1. Baseline National Institutes of Health Stroke Scale (NIHSS) score \>5 at the time of randomization.
2. NIHSS 3-5 with disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis/ loss of hand or leg function as established by the treating team in context of the patient's life.
6. The presence of a Target Mismatch defined as:
1. Ischemic Core \< 50cc (defined on NCCT/CTP\* or DWI-MRI)
2. Mismatch Volume (TMax \>6sec lesion - Core volume lesion) \>10cc
3. Mismatch Ratio \>1.4
7. Patient treatable within 12 hours of symptom onset. Symptoms onset is defined as the point in time the patient was last seen well (at baseline). Treatment start is defined as the time of arterial puncture.
8. Informed consent obtained from patient or acceptable patient surrogate

1. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).
2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having no residual disabling deficits and an NIHSS score of \<5 at randomization.
3. Significant ischemic changes in a territory other than the occluded site that in the opinion of the investigator could reduce the benefit of endovascular treatment.
4. Contra indication to imaging with MR or CT with contrast agents.
5. Infarct core \>1/3 occluded territory (MCA, ACA, or PCA) qualitatively or \>50 mL quantitatively (determined by NCCT, CTP or DWI).
6. Any terminal illness such that patient would not be expected to survive more than 1 year.
7. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
8. Any imaging findings suggestive of futile recanalization in the judgment of the local investigator.
9. Premorbid disability (mRS ≥3).
10. Inability to initiate endovascular treatment within 12 hours of last seen well.
11. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.
12. Baseline blood glucose of \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol).
13. Known history of hereditary or acquired hemorrhagic diathesis and/or platelet count \<100,000/uL.
14. Known renal failure as defined as serum creatinine levels \> 3.0 mg/dL.
15. Presumed septic embolus or suspicion of bacterial endocarditis.
16. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
17. History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
18. Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation)
19. Subject participating in a study involving an investigational drug or device that would impact this study
20. Known pregnancy
21. Prisoner or incarceration
22. Known acute symptomatic COVID-19 infection

Contacts and Locations

Study Contact

Denise McCarthy, MPPM RN

CONTACT

1-878-261-6015

mccarthydj@upmc.edu

Emma Gyurisin, MPH

CONTACT

4126779128

gyurisinek2@upmc.edu

Principal Investigator

Raul G Nogueira, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Raul Nogueira

Raul G Nogueira, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02

Study Completion Date2027-11

Study Record Updates

Study Start Date2024-04-02

Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

Stroke
Ischemic

Additional Relevant MeSH Terms

Ischemic Stroke