Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular ThrombectomySWISS-PRECISENCT06375174
PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY)
An observational study of Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy, run by Dr. med. Carlo Cereda at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy
- What is being tested?
- Thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jan 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with Posterior circulation acute ischemic stroke due to large vessel occlusion of the vertebral or basilar artery needing endovascular thrombectomy
Who may be able to join
- 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
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neurocenter of Southern Switzerland, Ospedale Civico
Lugano, Canton Ticino, CH-6900
About this study
Official title: 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
Read the 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.
- Being tested
- Thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyProcedure or surgery
All procedures correspond to standard care and clinical routine
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS score
Ordinal distribution of modified Rankin Scale (mRS) Scores 90 days after thrombectomy treatment
Measured: 5±1 days or discharge, 30±7 days, and 90±14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start9 Jan 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular ThrombectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. med. Carlo Cereda
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. med. Carlo Cereda, Ospedale Civico, Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375174
- Sponsor's protocol ID
- NSISTRCR_2202
- Acronym
- SWISS-PRECISE
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWISS-PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY)
- ClinicalTrials.gov ID
- NCT06375174
- Acronym / sponsor ID
- SWISS-PRECISE / NSISTRCR_2202
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr. med. Carlo CeredaOther government
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Posterior circulation acute ischemic stroke due to large vessel occlusion of the vertebral or basilar artery needing endovascular thrombectomy
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThrombectomyAll procedures correspond to standard care and clinical routine | Procedure or surgery | – |
Primary outcome
mRS score
Time frame: 5±1 days or discharge, 30±7 days, and 90±14 days
Ordinal distribution of modified Rankin Scale (mRS) Scores 90 days after thrombectomy treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy, run by Dr. med. Carlo Cereda at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS score (time frame: 5±1 days or discharge, 30±7 days, and 90±14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.