Recruiting
Phase 3

Endovascular Stenting

Sponsor:

ProMedica Health System

Code:

NCT07356284

Conditions

Brain Stroke

Stenting Treatment

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mechanical Thrombectomy plus adjunct stenting

Mechanical Thrombectomy

Study Details

Brief summary:

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.

Conditions

Brain Stroke

Stenting Treatment

Acute Ischemic Stroke

Study ID

NCT07356284

Start date

May 19, 2026

Status verified date

Feb, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

342 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting

Patients will have mechanical thrombectomy (MT) and stenting

active comparator: Randomized to Mechanical Thrombectomy (MT)

Patients will only have mechanical thrombectomy (MT) done

Interventions

Mechanical Thrombectomy plus adjunct stenting

Mechanical thrombectomy and adjunct stentiing

Mechanical Thrombectomy

Mechanical thrombectomy only

Primary outcome measure

  • Primary Efficacy Endpoint [ Time Frame: 90 (+/- 30) days post treatment ]
  • Primary Safety Endpoint [ Time Frame: 90 (+/- 30 ) days post treatment ]

Central Contacts and Locations

Central contacts

Locations

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Principal Investigator:

Mouhammad Jumaa, MD

More Information

Sponsor

ProMedica Health System

Last update posted

May 22, 2026

Last verified

Feb, 2026

Keywords

  • mechanical thrombectomy
  • Acute Ischemic stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ProMedica Health System on 2026-05-22.