Mejoría química del tratamiento que recanaliza (destapa”) las arterias cerebrales en pacientes con ictus agudo tratados con diferentes dispositivos que permiten la extracción mecánica del trombo cerebral

Phase 1

• Conditions: Cerebral Embolectomy in patients with acute stroke; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-002195-40-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-17
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Patients with symptomatic large vessel occlusion (LVO) in the anterior, middle or posterior cerebral arteries treated with MT resulting in a mTICI score 2b at end of the procedure
2.Estimated delay to onset of rescue intraarterial rt-PA or placebo administration <24 hours from symptom onset, defined as the point in time the patient was last seen well
3.No significant pre-stroke functional disability (modified Rankin scale 0-1)
4.Age =18
5.ASPECTS >6 on non-contrast CT (NCCT) scan if symptoms lasting <4.5 hours or ASPECTS > 6 on CT-Perfusion (CTP) if symptoms >4.5 <24 hours. In both cases, ASPECTS is obtained within <75 minutes of the onset of mechanical thrombectomy
6.Informed consent obtained from patient or acceptable patient surrogate
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1.NIHSS score on admission >25
2.Contraindication to IV t-PA as per local national guidelines (except time to therapy)
3.Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy
4.Female who is pregnant or lactating or has a positive pregnancy test at time of admission
5.Current participation in another investigation drug or device treatment study (except observational study i.e.: RACECAT)
6.Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
7.Known coagulopathy, INR >1.7 or use of novel anticoagulants <12h from symptom onset
8.Platelets <50,000
9.Renal Failure as defined by a serum creatinine >3.0 mg/dl (or 265.2 µmol/l) or glomerular Filtration Rate [GFR] <30
10.Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
11.Any hemorrhage on CT/MRI
12.Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
13.Suspicion of aortic dissection
14.Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
15.History of life threatening allergy (more than rash) to contrast medium
16.SBP >185 mmHg or DBP >110 mmHg refractory to treatment
17.Serious, advanced, terminal illness with anticipated life expectancy <6 months
18.Pre-existing neurological or psychiatric disease that would confound evaluation
19.Presumed vasculitis or septic embolization
20.Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified