PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY) (SWISS-PRECISE)

SWISS-PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY)

We hypothesize that patients with a favorable Critical Area Perfusion Score (CAPS≤3) on cerebral perfusion imaging will have a favorable response to revascularization by thrombectomy and that patients with a CAPS>3 will not

Study Overview

• Status: Active, not recruiting
• Conditions: Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy
• Intervention / Treatment: Procedure: Thrombectomy

Detailed Description

PRECISE is a multicenter, prospective, observational cohort study. SWISS-PRECISE is a Switzerland Based spin-off of PRECISE with the intention to perform a final pooled analysis of data.

All procedures correspond to standard care and clinical routine. Perfusion imaging will be acquired prior to thrombectomy treatment. Enrolled patients have undergone standard of care baseline imaging with CT or MRI that includes angiography and cerebral perfusion imaging; therefore will be performed a control-MRI (or CT scan) after 24 hours and/or within 5±1 days from the thrombectomy, or before discharge.

Study procedures include the standard of care clinical follow-up assessments at uniform time intervals (5±1 days or discharge, 30±7 days, and 90±14 days). Data that will be collected on participants include: (1) all brain imaging; (2) demographics; (3) limited history; (4) blood pressure and vital signs before, during and after thrombectomy treatment; (5) NIHSS before and after thrombectomy treatment, at hospital discharge and at days 30 and 90 (if conducted in person); (6) discharge disposition; (7) modified Rankin Scale score prior to stroke, at discharge, and at days 30 and 90 (mRS will be assessed either in person or by phone); and (8) Quality of Life Assessment at day 90.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Lugano, Ticino, Switzerland, CH-6900
      • Neurocenter of Southern Switzerland, Ospedale Civico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with Posterior circulation acute ischemic stroke due to large vessel occlusion of the vertebral or basilar artery needing endovascular thrombectomy

Description

Inclusion Criteria:

• 1. Signs and symptoms consistent with an acute posterior circulation ischemic stroke 2. Baseline modified Rankin Scale (mRS) score ≤2 prior to qualifying stroke 3. Subjects age is 18-89 years, 90 or more if fully independent 4. Baseline National Institutes of Health Stroke Scale Score >4 and remains >4 immediately prior to thrombectomy treatment 5. Stroke symptoms began within 48 hours of thrombectomy treatment. Stroke onset is defined as the time the patient was last known to be at his/her neurologic baseline. Wake-up strokes are eligible if they meet the above time limits.

  6. Endovascular thrombectomy for BAO or PC-LVO planned as standard-of-care therapy (included aspiration, thrombectomy, angioplasty, stent placement, intravenous intrarterial GPIIb-IIIa inhibitor infusion) 7. Time of arterial puncture (femoral or radial artery) occurred (or expected to occur) within 120 minutes of CT or MR imaging study completion 8. Patient or Legally Authorized Representative has signed the study Informed Consent form

Exclusion Criteria:

• 1. Symptomatic stroke in another vascular territory (ie - MCA or ACA) 2. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months 3. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional outcomes evaluation 4. Any condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject Imaging

  1. Acute symptomatic arterial occlusions in more than one vascular territory on CTA (ie - associated anterior circulation LVO of the internal, middle, or anterior cerebral artery).
  2. Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm or arteriovenous malformation
  3. Mass effect with significant herniation above the cerebral tentorium or below the foramen magnum
  4. Intracranial stent implanted in the same vascular territory that precludes safe deployment/removal of neurothrombectomy device.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS score	Ordinal distribution of modified Rankin Scale (mRS) Scores 90 days after thrombectomy treatment	5±1 days or discharge, 30±7 days, and 90±14 days

Collaborators and Investigators

• Sponsor: Dr. med. Carlo Cereda

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: NSISTRCR_2202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No