Optical Coherence Tomography Clinical Trial
Official title:
Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation
Evidence regarding the role of early (<24 hours) antithrombotics post-revascularization with
either intravenous thrombolysis (IVT), endovascular thrombectomy (EVT), or a combination of
both remains scarce. In 2018 the American Heart Association/American Stroke Association
changed their recommendation, stating that the risk of antithrombotic therapy within the
first 24 hours after treatment with IVT (with or without EVT) is uncertain. This was changed
after data emerged that early antithrombotics may be safe and may improve outcomes in select
patients undergoing EVT.
Recently the investigators showed for the first time that significant residual basilar
thrombus can exist after EVT despite complete angiographic revascularization using
endovascular optical coherence tomography imaging. This residual thrombus could cause ongoing
function-limiting strokes with occlusion of vital basilar perforators after EVT. Therefore,
the investigators propose a prospective,non-randomized safety study to evaluate optical
coherence tomography guided antithrombotic management for patients with confirmed residual
thrombus after EVT for basilar occlusion.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 14, 2021 |
Est. primary completion date | October 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients deemed candidates for endovascular thrombectomy(EVT) for basilar artery occlusion. As no robust guidelines exist for the role of EVT in patients with acute basilar artery occlusion, the decision for EVT is made by a team of stroke neurologist and neuro-interventionalist at our regional stroke center. Exclusion Criteria: - High-density lesion consistent with hemorrhage of any degree. - Significant established infarct size. - Contraindication to receiving post-revascularization antithrombotics for any reason (history of major hemorrhage in the past six months, hereditary or acquired bleeding diathesis, major surgery within last three months, platelets <100 X 109 /L, coagulation factor deficiency, already on anticoagulant that would not allow administration of UFH) - Informed consent is not or cannot be obtained. - Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission. - Other serious, advanced, or terminal illness. - Patients who require hemodialysis or peritoneal dialysis. - Uncontrolled hypertension defined as systolic blood pressure>185 mm Hg or diastolic blood pressure>110mm Hg that cannot be controlled except with continuous parenteral antihypertensive medication |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Heath Sciences Center | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Jeong HG, Kim BJ, Yang MH, Han MK, Bae HJ, Lee SH. Stroke outcomes with use of antithrombotics within 24 hours after recanalization treatment. Neurology. 2016 Sep 6;87(10):996-1002. doi: 10.1212/WNL.0000000000003083. Epub 2016 Aug 12. — View Citation
Pasarikovski CR, Ramjist J, da Costa L, Black SE, Yang V. Optical coherence tomography imaging after endovascular thrombectomy for basilar artery occlusion: report of 3 cases. J Neurosurg. 2019 Aug 23:1-6. doi: 10.3171/2019.5.JNS191252. [Epub ahead of print] — View Citation
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. Review. Erratum in: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:. — View Citation
Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Favorable outcome | Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3. | 90 days | |
Secondary | Symptomatic Intracranial Hemorrhage | 24 hours CT imaging ± 8 hours. | ||
Secondary | Incidence of residual thrombus | Fraction of patients with residual thrombus after endovascular thrombectomy as observed with optical coherence tomography | Immediately after endovascular thrombectomy | |
Secondary | Excellent Outcome | Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2. | 90 days |
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