Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke

• Status: Active, not recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal vessel occlusion in the anterior circulation has currently become a matter of debate and is a relevant unanswered question in clinical practice.

The main objective is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation will have non-inferior functional outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects treated with combined IV t-PA and MT.

The secondary objectives are to study causes of mortality, dependency and quality of life in these AIS patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Medtronic
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. Informed consent as documented by signature

2. Age ≥ 18

3. Clinical signs consistent with an acute ischemic stroke

4. Neurological deficit with a NIHSS of ≥ 5 and < 30 (deficits judged to be clearly disabling at presentation)

5. Patient is eligible for intravenous thrombolysis

6. Patient is eligible for endovascular treatment

7. Randomization no later than 4 hours 15 minutes after stroke symptom onset and initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms onset (onset time is measured from the time when the subject was last seen well)

8. Occlusion (TICI 0-1) of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography, accessible for MT

9. Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) greater than or equal to 4 (≥ 4) based on baseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS positive)

Exclusion Criteria:

1. Acute intracranial hemorrhage

2. Any contraindication for IV t-PA

3. Pre-treatment with IV t-PA

4. In-hospital stroke

5. Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.

6. Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys

7. Known current participation in a clinical trial (investigational drug or medical device)

8. Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) < 30 mL/min or requirement for hemodialysis or peritoneal dialysis

9. Severe comorbid condition with life expectancy less than 90 days at baseline

10. Known advanced dementia or significant pre-stroke disability (mRS score of ≥2)

11. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)

12. Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.

13. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).

14. Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT

15. Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)

16. Radiological confirmed evidence of cerebral vasculitis

17. CTA or MRA evidence of carotid artery dissection

18. Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA