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

NCT06375174 | Active Not Recruiting

• 1 other identifier: NSISTRCR_2202
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Thrombectomy PROCEDURE

All procedures correspond to standard care and clinical routine

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \. 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.
• \. 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

You may not qualify if:

• \. 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
• 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).
• Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm or arteriovenous malformation
• Mass effect with significant herniation above the cerebral tentorium or below the foramen magnum
• Intracranial stent implanted in the same vascular territory that precludes safe deployment/removal of neurothrombectomy device.

Sponsors & Collaborators

• Dr. med. Carlo Cereda: lead

Study Sites (1)

Neurocenter of Southern Switzerland, Ospedale Civico

Lugano, Canton Ticino, CH-6900, Switzerland

Location

MeSH Terms

Interventions

Thrombectomy

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr med.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: January 9, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)