Clinical trial NCT05611242: Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
Official title: Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Ischemic Stroke
Thrombectomy
Lead sponsor: Mercy Health Ohio
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design).
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. 18 to 79 years of age (before the 80th birthday)
2. Presenting with symptoms consistent with AIS
3. 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%
4. NIHSS ≥ 4
5. Ability to randomize and start endovascular therapy within 16 hours of stroke onset
6. Pre-stroke mRS score 0-2
7. Ability to obtain signed informed consent
8. 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.
9. Acute Neurological Deficit with Imaging evidence of Tandem Lesion:

   Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion
10. Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy

Exclusion Criteria:

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

   * Midline shift or herniation
   * Evidence of intracranial hemorrhage
   * Mass effect with effacement of the ventricles
5. Acute bilateral strokes
6. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
7. Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
8. 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
9. Baseline platelet count \<100,000 per microliter (μl)
10. Life expectancy less than one year prior to stroke onset
11. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
12. 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
13. Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)

Primary outcomes:
measure: 90-day Modified Rankin Scale ordinal shift
timeFrame: Time Frame: 90 days post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Pomona
country: United States
facility: Pomona Valley
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center/Mils Peninsula Medical Center
state: California
city: Coral Gables
country: United States
facility: Baptist Health South Florida
state: Florida
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Marietta
country: United States
facility: WellStar Health System, Inc
state: Georgia
city: Chicago
country: United States
facility: Ascension/Alexian Brothers Health System
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Munster
country: United States
facility: Munster Community Hospital
state: Indiana
city: Lexington
country: United States
facility: Baptist Healthcare Systems, Inc
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center at Shreveport
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Flint
country: United States
facility: McLaren Flint
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
state: Michigan
city: Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Saint Louis
country: United States
facility: SSM Health DePaul Hospital
state: Missouri
city: Piscataway
country: United States
facility: Rutgers, The State University
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Bay Shore
country: United States
facility: Northwell Health- South Shore University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center
state: Ohio
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Semmes-Murphey Foundation
state: Tennessee
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development
state: Texas
city: Houston
country: United States
facility: HCA Houston Kingwood
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia Univeristy
state: West Virginia
Study officials:
affiliation: Mercy Health St. Vincent Medical Center
name: Osama O Zaidat, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: