No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
342 (estimated)
Sponsor
ProMedica Health System · Other
Who this trial is looking for
This trial is looking for patients aged 18 to 80 who have had a recent stroke and still have a blockage in a brain artery after treatment. Taking part involves undergoing a procedure to clear the blockage while also receiving stenting treatment if needed.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 80 years old
I have had symptoms of a stroke
I have imaging showing a blockage in the Internal Carotid Artery or Middle Cerebral Artery
I have 70-99% blockage remaining after a clot retrieval attempt
I have a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher
I can start within 24 hours of my stroke
I can provide signed consent
I have an ASPECTS score of 6 or higher
You may not be able to join if
I am pregnant or have a positive pregnancy test
I have a severe allergy to contrast media
I have a midline shift, herniation, or intracranial hemorrhage
I have had a stroke on both sides of my brain
I cannot take antiplatelet medications or contrast agents
I have a recent diagnosis of atrial fibrillation
I have been diagnosed with certain tumors that require surgery
My platelet count is below 80,000 per microliter
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. 18 to 80 years of age
2. Presenting with symptoms consistent with AIS
3. 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 follow…
Inclusion Criteria:
1. 18 to 80 years of age
2. Presenting with symptoms consistent with AIS
3. 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
4. NIHSS ≥ 6
5. Ability to randomize within 24 hours of stroke onset.
6. Pre-stroke mRS score 0-2
7. Ability to obtain signed informed consent.
8. ASPECTS Score ≥ 6 by non-contrast CT scan
9. Score-ICAD score of ≥11 points at screening and/or persistent stenotic occlusion of ≥70% after MT
10. If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay.
11. For subjects presenting \>6 hours from stroke onset, infarct core volume \<50 cc quantified by CTP
Exclusion Criteria:
1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications.
3. CT evidence of the following conditions:
* Midline shift or herniation
* Evidence of intracranial hemorrhage
* Mass effect with effacement of the ventricles
4. Acute bilateral strokes
5. Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
6. 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
7. 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
8. Baseline platelet count \<80,000 per microliter (µl)
9. Life expectancy less than one year prior to stroke onset
10. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes.
11. 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
12. New diagnosis of atrial fibrillation or a history of atrial fibrillation
13. Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel
14. 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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