Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Обзор

The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).

Подробное описание

Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design).

Patients presenting with symptoms of AIS in the anterior circulation with proximal carotid occlusion or severe stenosis will be assigned to either:

ARM1 (Control): Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion treatment with non-stenting approach (MT+CAT)

VERSUS

ARM2 (Intervention): Acute carotid stenting (ACS) approach constitutes BMM+IAT with acute carotid stenting (ACS) of the extracranial proximal carotid artery, spanning the cervical internal carotid artery (ICA), ICA origin, and the distal common carotid artery (CCA, across the bifurcation) as in the example of left (L) carotid stenting figure below (MT+CAS)

Randomization will be 1:1

Mechanical thrombectomy and proximal angioplasty or stenting will be performed with an FDA-cleared devices in accordance with the instructions for use (IFU). The order of each procedure (revascularization of the proximal extra-cranial carotid lesion first or after the intracranial lesion) will be left at discretion of the treating proceduralist.

Each treated patient will be followed and assessed for the primary outcome at 3 months and one year after randomization by an independent adjudicator not involved in the procedure. Optional utilization of remote assessment of NIHSS, mRS scale may be provided to selected site

Вмешательства

• Процедура MT+CAS with IV-AP
  Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added intravenous antiplatelet therapy.
• Процедура MT+CAS with PO-AP
  Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy.
• Процедура MT+CAT with PO-AP
  Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy

Первичные конечные точки

• 90-day Modified Rankin Scale ordinal shift [Срок оценки: Time Frame: 90 days post randomization]

Критерии участия

Критерии включения

• 18 to 79 years of age (before the 80th birthday)
• Presenting with symptoms consistent with AIS
• Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis related to atherosclerosis requiring treatment on non-invasive imaging ≥70%
• NIHSS ≥ 4
• Ability to randomize and start endovascular therapy within 16 hours of stroke onset
• Pre-stroke mRS score 0-2
• Ability to obtain signed informed consent
• ASPECTS Score ≥7 via non-contrast CT or MRI (DWI) for subjects ≤6 hours from stroke onset OR ASPECTS Score ≥7 + infarct core volume <50 cc quantified by CTP (rCBF<30%) OR <25 cc quantified by MRI-DWI (AxBxC/2) for subjects with endovascular therapy starting between >6h to 16 hours from stroke onset, given the need for antiplatelet therapy.
• Acute Neurological Deficit with Imaging evidence of Tandem Lesion:

Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion

• Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy

Критерии исключения

• Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
• Known severe allergy (more than a rash) to contrast media uncontrolled by medications
• Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) despite medication
• CT evidence of the following conditions:

• Midline shift or herniation
• Evidence of intracranial hemorrhage
• Mass effect with effacement of the ventricles
• Acute bilateral strokes
• Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
• Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
• Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7 or Partial Thromboplastin Time (PTT) > 3 times of normal
• Baseline platelet count <100,000 per microliter (μl)
• Life expectancy less than one year prior to stroke onset
• Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
• Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
• Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 51 центр

• Mobile Infirmary Medical Center — Mobile
• Glendale Adventist Medical Center — Glendale
• University of California, Irvine — Irvine
• Pomona Valley — Pomona
• Sutter Institute for Medical Research — Sacramento
• California Pacific Medical Center/Mils Peninsula Medical Center — San Francisco
• Boca Raton - Baptist Health — Boca Raton
• Delray Medical Center — Delray Beach
• … и ещё 43 центра

Публикации

• Al Kasab S, Nguyen TN, Abdalkader M, Rai A, Boo S, Kass-Hout T, Hurley M, Sultan-Qurraie A, Lin E, Given C, Elijovich L, Badruddin A, Janjua N, Jung R, Khandelwal P, Southwood C, Majjhoo A, Guerrero WR, Mueller-Kronast N, Alshekhlee A, Martinez-Gutierrez JC, Ezzeldin M, Cress M, Niazi M, Paul A, Snelling B, Razak A, Grandhi R, Morgan L, Settecase F, English J, Fernandez P, Zacharatos H, Alexander PMID 41573330

Идентификаторы

NCT: NCT05611242 · 0525052522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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