Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation
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|ClinicalTrials.gov Identifier: NCT04121611|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke of Basilar Artery Optical Coherence Tomography Antithrombotics Endovascular Thrombectomy||Drug: Unfractionated heparin Drug: Acetylsalicylic Acid (ASA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation|
|Actual Study Start Date :||October 14, 2019|
|Estimated Primary Completion Date :||October 14, 2021|
|Estimated Study Completion Date :||December 14, 2021|
Experimental: Optical coherence tomography confirmed residual thrombus
Drug: Unfractionated heparin
Drug: Acetylsalicylic Acid (ASA)
No Intervention: Optical coherence tomography confirmed no residual thrombus
Best medical management
- Favorable outcome [ Time Frame: 90 days ]Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
- Symptomatic Intracranial Hemorrhage [ Time Frame: 24 hours CT imaging ± 8 hours. ]
- Incidence of residual thrombus [ Time Frame: Immediately after endovascular thrombectomy ]Fraction of patients with residual thrombus after endovascular thrombectomy as observed with optical coherence tomography
- Excellent Outcome [ Time Frame: 90 days ]Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121611
|Contact: Christopher R Pasarikovski, MDfirstname.lastname@example.org|
|Contact: Victor XD Yang, MD||416-480-6100 ext email@example.com|
|Sunnybrook Heath Sciences Center||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Christopher R Pasarikovski, MD 6475500862 firstname.lastname@example.org|