Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy with proximal carotid artery angioplasty versus acute stenting during thrombectomy in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis) within 24 hours of symptom onset.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mercy Health Ohio
• Treatments: Cangrelor; Platelet Aggregation Inhibitors

Criteria

Inclusion Criteria:

1. 18 to 85 years of age

2. Presenting with symptoms consistent with AIS

3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis requiring treatment on non-invasive imaging ≥70%

4. NIHSS ≥ 4

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 CT scan or MRI (DWI) ≤6hours from stroke onset, and ASPECT >6 (7-10) OR Core≤50cc on MRP, CTP or MRI >6h-24 hours from stroke onset, given the need for antiplatelet therapy

9. Imaging obtained within 24 hours (after the first symptoms or last seen well.

10. Arterial Access Obtained < 25 hours from stroke symptoms onset.

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. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) despite medication

4. CT evidence of the following conditions:

• Midline shift or herniation

• Evidence of intracranial hemorrhage

• Mass effect with effacement of the ventricles

5. Acute bilateral strokes

6. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.

7. Intracranial tumors other than small meningioma that doesn't not require surgery for one year post randomization

8. 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

9. Baseline platelet count <30,000 per microliter (µl)

10. Life expectancy less than one year prior to stroke onset

11. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes

12. 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