Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke

• Register: ClinicalTrials.gov
• Last refreshed on: 20 March 2023
• Main ID: NCT03192332
• Date of registration: 12/06/2017
• Prospective Registration: Yes
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke SWIFT DIRECT
• Scientific title: Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke
• Date of first enrolment: November 29, 2017
• Target sample size: 410
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03192332
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Austria, Canada, Finland, France, Germany, Spain, Switzerland, United Kingdom

Contacts

• Name: Jan Gralla, Prof. Dr.
• Affiliation: Dept. of Neuroradiology, Inselspital Bern

• Name: Urs Fischer, Prof. Dr.
• Affiliation: Dept. of Neurology, Inselspital Bern

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ischemic Stroke

Intervention(s)

Drug: Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA)

Device: Stent-retriever thrombectomy with revascularization device of the Solitaire™ type

Primary Outcome(s)

Score in modified Rankin Scale (mRS) [Time Frame: 90 days after randomization]

Secondary Outcome(s)

Modified Rankin Scale (mRS) shift analysis [Time Frame: day 0 and 90 days after randomization]

National Institute of Health Score Scale (NIHSS) [Time Frame: day 0 and day 1 after randomization]

Serious adverse events [Time Frame: day 0 until 90 days after randomization]

Thrombolysis in Cerebral Infarction (TICI) scale [Time Frame: day 0 and day 1 after randomization]

Quality of life assessed by questionnaire [Time Frame: 90 days after randomization]

Intracranial hemorrhage [Time Frame: day 1 after randomization]

Mortality [Time Frame: 90 days after randomization]

Overall costs incurred during hospitalisation [Time Frame: 90 days after randomization]

Secondary ID(s)

2017-00974

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic