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

Acute Ischemic Stroke Clinical Trial

— PICASSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611242
• Other study ID #: 0525052522
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: Mercy Health Ohio
• Contact: Jasmine M Olvany, PhD
• Phone: (419)-251-4264
• Email: jolvany[@]mercy.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 404
• Est. completion date: May 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• 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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	West Virginia Univeristy	Morgantown	West Virginia
United States	Munster Community Hospital	Munster	Indiana
United States	SSM Health DePaul Hospital	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Health Ohio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day Modified Rankin Scale ordinal shift	Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death.; 0 = No symptoms at all.; No significant disability despite symptoms; able to carry out all usual duties and activities.; Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.; Moderate disability requiring some help, but able to walk without assistance.; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.; Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.; Death	Time Frame: 90 days post randomization