CLINICAL TRIAL / NCT05611242
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
- Interventional
- Active
- NCT05611242
Contact Information
- Ahmad Chahine
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
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).
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
Gender
All
Age Group
18 Years to 79 Years
Accepting Healthy Volunteers
No
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)