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

Mercy Health Ohio

Status and phase: Enrolling; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Procedure: MT+CAS with IV-AP; Procedure: MT+CAS with PO-AP; Procedure: MT+CAT with PO-AP

Study type: Interventional

Funder types: Other

Identifiers

NCT05611242

0525052522

Details and patient eligibility

About

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).

Full 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

Enrollment: 404 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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404 participants in 2 patient groups

MT+CAT

Experimental group

Description:

Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion angioplasty or aspiration (MT+CAT)

Treatment:

Procedure: MT+CAT with PO-AP

MT+CAS

Experimental group

Description:

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). Within the stenting arm, there will be 2 different subgroups based on the antiplatelet treatment protocol per the site standard of care (oral antiplatelet or IV antiplatelet medication (e.g., Cangrelor or others).

Treatment:

Procedure: MT+CAS with PO-AP

Procedure: MT+CAS with IV-AP