search
Back to results

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

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IV-Antiplatelet Drugs
MT+CAS with IV-AP
MT+CAS with PO-AP
MT+CAT with PO-AP
PO-Antiplatelet Drugs
RX ACCULINK Carotid Stent System
Balloon Angioplasty
EMBOGUARD Balloon Guide Catheter
Sponsored by
Mercy Health Ohio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Stroke, Ischemic Stroke, Thrombectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 to 85 years of age 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 within 24 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 MRI DWI (AxBxC/2) or CTP (rCBF<30%) for subjects >6h to -24 hours from stroke onset, given the need for antiplatelet therapy. Imaging obtained within 24 hours (after the first symptoms or last seen well. Arterial Access Obtained < 25 hours from stroke symptoms onset. Both study groups must adhere to identical blood pressure (BP) recommendations, which will be dependent on the cerebral perfusion status. Individuals with TICI2b or higher scores will be subject to BP recommendations ranging from 100-140 mmHg in cases of reperfusion and 120-180 mmHg in instances of no reperfusion and no evidence of intracranial hemorrhage (ICH) (TICI score < 2b). Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion Exclusion Criteria: 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)

Sites / Locations

  • Mercy Health St. Vincent Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MT+CAT

MT+CAS

Arm 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)

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).

Outcomes

Primary Outcome Measures

Utility-weighted 90-day Modified Rankin Score
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

Secondary Outcome Measures

Full Information

First Posted
November 2, 2022
Last Updated
September 14, 2023
Sponsor
Mercy Health Ohio
search

1. Study Identification

Unique Protocol Identification Number
NCT05611242
Brief Title
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
Acronym
PICASSO
Official Title
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Health Ohio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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) within 24 hours of symptom onset.
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 angioplasty or aspiration (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, with stratification by: 1) age, 2) ASPECT score, 3. National Institute of Health Stroke Scale (NIHSS), 4) time from onset to randomization CTA imaging confirming ICA occlusion/tandem lesion, 5) degree of proximal extra-cranial carotid stenosis (complete occlusion versus stenosis), 6) IV thrombolysis administration, 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). Each arm will be assessed at the first interim analysis to consider dropping an arm if predetermined safety boundaries are exceeded. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Stroke, Ischemic Stroke, Thrombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
404 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT+CAT
Arm Type
Experimental
Arm 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)
Arm Title
MT+CAS
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
IV-Antiplatelet Drugs
Other Intervention Name(s)
Cangrelor (Kengreal), Eptifibatide, Tirofiban (Aggrastat), Abciximab (ReoPro)
Intervention Description
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). Each arm will be assessed at the first interim analysis to consider dropping an arm if predetermined safety boundaries are exceeded.
Intervention Type
Procedure
Intervention Name(s)
MT+CAS with IV-AP
Other Intervention Name(s)
Thrombectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
MT+CAS with PO-AP
Other Intervention Name(s)
Thrombectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
MT+CAT with PO-AP
Other Intervention Name(s)
Thrombectomy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PO-Antiplatelet Drugs
Other Intervention Name(s)
Acetylic salicylic acid (Aspirin), Clopidogrel (Plavix), Tricagrelor (Brilinta)
Intervention Description
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). Each arm will be assessed at the first interim analysis to consider dropping an arm if predetermined safety boundaries are exceeded.
Intervention Type
Device
Intervention Name(s)
RX ACCULINK Carotid Stent System
Intervention Description
Abbott Carotid Stenting System used within the MT+CAS ARM
Intervention Type
Procedure
Intervention Name(s)
Balloon Angioplasty
Intervention Description
A medical procedure that is used to treat the narrowing and blocking of the the blood vessels.
Intervention Type
Device
Intervention Name(s)
EMBOGUARD Balloon Guide Catheter
Intervention Description
The primary purpose of a balloon guide catheter is to temporarily block blood flow in the target vessel or artery during procedures like clot retrieval or the placement of embolic coils in the brain.
Primary Outcome Measure Information:
Title
Utility-weighted 90-day Modified Rankin Score
Description
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
Time Frame: 90 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 85 years of age 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 within 24 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 MRI DWI (AxBxC/2) or CTP (rCBF<30%) for subjects >6h to -24 hours from stroke onset, given the need for antiplatelet therapy. Imaging obtained within 24 hours (after the first symptoms or last seen well. Arterial Access Obtained < 25 hours from stroke symptoms onset. Both study groups must adhere to identical blood pressure (BP) recommendations, which will be dependent on the cerebral perfusion status. Individuals with TICI2b or higher scores will be subject to BP recommendations ranging from 100-140 mmHg in cases of reperfusion and 120-180 mmHg in instances of no reperfusion and no evidence of intracranial hemorrhage (ICH) (TICI score < 2b). Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanner J Gray-DuVall, BS
Phone
419-251-2338
Email
tgray-duvall@mercy.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmine Olvany, Ph.D.
Email
jolvany@mercy.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama O Zaidat, MD, MS
Organizational Affiliation
Mercy Health St. Vincent Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Health St. Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama O Zaidat, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All shared data will be aggregate.

Learn more about this trial

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

We'll reach out to this number within 24 hrs