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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting | Experimental | Patients will have mechanical thrombectomy (MT) and stenting |
|
| Randomized to Mechanical Thrombectomy (MT) | Active Comparator | Patients will only have mechanical thrombectomy (MT) done |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Thrombectomy plus adjunct stenting | Procedure | Mechanical thrombectomy and adjunct stentiing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint | • Utility weighted 90-day Modified Rankin Score (mRS) | 90 (+/- 30) days post treatment |
| Primary Safety Endpoint | Rate of symptomatic intracranial hemorrhage (sICH: Parenchymal hematoma Type 2 (PH2) with ≥4 points NIHSS worsening) at 24 hours (-12/+16 hours) from randomization) | 90 (+/- 30 ) days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoint | Any neurological deterioration with ≥4 points worsening on NIHSS before discharge and unrelated to sICH or sedation (In addition to the routine 24-hour CT/Magnetic Resonance Imaging (MRI) scan, repeat neuroimaging is mandatory for any subsequent neurological deterioration at any time during hospitalization). | 8 (+/- 3) days or Discharge post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Endpoints | Utility weighted one-year Modified Rankin Score (mRS) | 1 year (+/-60) days post treatment |
| Secondary Efficacy Endpoints | 90-day and one-year mRS ordinal shift (mRS 5 and 6 combined) |
Inclusion Criteria:
Exclusion Criteria:
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.
CT evidence of the following conditions:
Acute bilateral strokes
Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
Intracranial tumors other than small meningioma, that do not require surgery for at least one year post randomization. Small meningioma is defined as a lesion measuring ≤20mm in maximum diameter or ≤4cm3 in volume, with no associated mass effect, peritumoral edema, or progressive neurological symptoms
Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
Baseline platelet count <80,000 per microliter (µl)
Life expectancy less than one year prior to stroke onset
Participation in another randomized clinical trial that could confound the evaluation of the study outcomes.
Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
New diagnosis of atrial fibrillation or a history of atrial fibrillation
Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel
Vessel dissection including any of the following: presence of dissection flap, false lumen, contrast stagnation in the vessel wall, and/or improving stenosis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sami Al Kasab, MD | Contact | 4192913498 | alkasab@musc.edu | |
| Mouhammad Jumaa, MD | Contact | Mouhammad.JumaaMD@ProMedica.org |
| Name | Affiliation | Role |
|---|---|---|
| Sami Al Kasab, MD | Medical University of South Carolina | Principal Investigator |
| Mouhammad Jumaa, MD | ProMedica Toledo Hospital | Principal Investigator |
| Tanya Siddiqui |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProMedica Toledo Hospital | Recruiting | Toledo | Ohio | 43606 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| Mechanical Thrombectomy | Device | Mechanical thrombectomy only |
|
| Secondary Safety Endpoint | Embolization into new territory (ENT) | Immediate post treatment |
| Secondary Safety Endpoint | Distal embolization (DE) | Immediate post treatment |
| Secondary Safety Endpoint | Major vessel injury (perforation, dissection) | Immediate post treatment |
| Secondary Safety Endpoint | Ipsilateral recurrent stroke in the territory of the index artery from Day 1 through 1-year | 1 year (+/- 60) days post treatment |
| Secondary Safety Endpoint | Rates of stent re-stenosis and stent thrombosis at the end of endovascular procedure | Immediate post treatment |
| Secondary Safety Endpoint | • Intracranial stent stenosis (WASID) and stent thrombosis at any time between Day 1 to one year follow up | 1 year (+/- 60) days post treatment |
| Secondary Safety Endpoint | Intracranial reintervention between Day 1 through 1-year (Any intervention or reintervention will be captured during that period) | 1 year (+/- 60) days post treatment |
| Secondary Safety Endpoints | Neurological and All-Cause Mortality at 90 days and 1-year | 1 year (+/- 60) days post treatment |
| Secondary Safety Endpoint | All serious adverse events (SAE), including serious adverse device events (SADE), serious adverse procedural events (SAPE), and unanticipated SAE. | 1 year (+/- 60) days post treatment |
| 90 (+/-30) days post treatment |
| Secondary Efficacy Endpoints | 90-day and one-year dichotomized mRS 0-2 outcome | 1 year (+/- 60) days post treatment |
| Secondary Efficacy Endpoints | 90-day and one-year dichotomized mRS 0-3 outcome | 1 year (+/-60) days post treatment |
| Secondary Efficacy Endpoints | Change in NIHSS at 24 hours (12-40 hours hours) from randomization | Immediate post treatment |
| Secondary Efficacy Endpoints | Change in NIHSS | Day 8 (+/-3) days or discharge post treatment |
| Secondary Efficacy Endpoints | NIHSS of 0-2 or improvement of 8 or more points | Day 8 (+/-) 3 days post treatment |
| Secondary Efficacy Endpoints | Rate of substantial reperfusion in the treatment arm at the end of procedure as TICI2b50 and TICI2b67 or higher | Immediately post treatment |
| Secondary Efficacy Endpoints | Procedural/time metrics: Door to qualifying image, Image to Puncture, Puncture to mTICI 2b-3, Puncture to end of the procedure (defined as the final angiogram on the affected hemisphere) | Immediate post treatment |
| Secondary Efficacy Endpoints | Length of hospital stay | Day 8 (+/- 3) days post treatment |
| Secondary Efficacy Endpoints | Effectiveness of stenting as measured by % stenosis within the MT adjunct stenting arm | 1 year (+/-60) days post treatment |
| ProMedica Health System |
| Study Director |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |