NCT06691230

Brief Summary

Endovascular mechanical thrombectomy is the standard of care for treating patients with a large-vessel occlusion acute ischemic stroke. However, in more than half of these patients, remaining distal vessel occlusions limit the benefit of this therapy. Currently the detection of residual vessel occlusions and the decision for further treatment by the operator is based on the 2D digital subtraction angiography (DSA) images. However, this technique has several limitations. Recently, a new imaging technique, with the possibility to acquire 3D time-resolved perfusion images directly in the operating room was introduced (the flat-panel detector computed tomography perfusion imaging, FDCTP). It can overcome the spatial limitations of 2D DSA, but the details on clinical validation and utility of FDCTP are currently lacking.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Nov 2024Feb 2028

Study Start

First participant enrolled

November 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

November 11, 2024

Last Update Submit

November 13, 2024

Conditions

Stroke, Acute, Ischemic

Keywords

Acute ischemic strokeLarge-vessel occlusionEndovascular mechanical thrombectomyFlat-panel detector computed tomography perfusion imagingPerfusion imaging

Outcome Measures

Primary Outcomes (1)

  • Detection of New Potentially Clinically Relevant Findings on FDCTP

    * Any hypoperfusion on processed FDCTP maps suggesting residual vessel occlusion within the target mechanical thrombectomy territory, not noted on the 2D DSA imaging (dichotomous variable: yes versus no) * Any hypoperfusion suggestive of vessel occlusion outside the target mechanical thrombectomy territory not observed on the 2D DSA i.e., a new vessel occlusion (dichotomous variable: yes versus no) * No hypoperfusion suggestive of residual vessel occlusion on FDCTP within the target mechanical thrombectomy territory, even thought the patient has incomplete reperfusion (\<eTICI3) on the 2D DSA (dichotomous variable: yes versus no) The primary outcome of the study will be assessed as a dichotomous variable (yes versus no), derived from a compound measure of clinically relevant findings based on the three interpretations described above.

    Up to 30 days post-procedure

Secondary Outcomes (1)

  • Diagnostic Sensitivity of 2D DSA vs. FDCTP in Detecting Residual Vessel Occlusion

    Up to 30 days post-procedure

Other Outcomes (5)

  • Eloquence of Hypoperfused Tissue

    Up to 30 days post-procedure

  • Concordance between FDCTP and standard imaging

    Up to 30 days post-procedure

  • Prevalence of the No-Reflow Phenomenon on FDCTP

    Up to 30 days post-procedure

  • +2 more other outcomes

Study Arms (1)

Flat-panel detector computed tomography perfusion imaging, FDCTP

Potential clinical use of FDCTP acquired during or shortly after the endovascular stroke treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with an acute ischemic stroke with large vessel occlusion who have undergone endovascular mechanical thrombectomy and received a (flat-panel detector computed tomography perfusion imaging (FDCTP) shortly after the treatment.

You may qualify if:

  • Informed consent as documented by a signature
  • The patients received mechanical thrombectomy or there was the intention to perform endovascular treatment, but only diagnostic angiography was performed.
  • Patients received FDCTP as clinically indicated by the treating physician.

You may not qualify if:

  • Inability to give consent due to insufficient knowledge of the project language
  • Inability to follow the clinically indicated visit at 90 days after the index stroke (e.g. patients living abroad).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Basel

Basel, 4031, Switzerland

NOT YET RECRUITING

University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Johannes Kaesmacher, Prof.

    University of Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Kaesmacher, Prof.

CONTACT

+41 31 66 4 05 38nctu@insel.ch

Seraina Beyeler, PhD

CONTACT

+41 31 632 39 70seraina.beyeler@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 15, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations

CH(2)