REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
ConditionRescue Stenting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcandis GmbH
About this trial
Goal of the study is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable CREDO® heal Stent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients, treated with CREDO® heal according to IFU
Over 18 years old
With acute persistent vascular occlusion due to high grade intracranial artery stenosis in the anterior or posterior circulation for which alternative therapy concepts are not considered or fail
With suspected underlying stenosis of the occluded artery, which is suitable for PTA and stenting according to the treating physician's assessment and/or persistent occlusion after failed recanalization by mechanical thrombectomy of the target region
Disqualifiers
With atherosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses > 70 %) with significant circulatory disturbance (haemodynamic infarct pattern and signs of restricted collaterals) and recurrent symptoms in spite of medical therapy
With contraindication against treatment with anti-platelet medication
Participating in another trial
Trial population
Patients who were treated with CREDO® heal due to acute ischemic stroke and proven occlusion with unsuccessful recanalization after endovascular treatment with mechanical thrombectomy and suspected underlying stenosis of the occluded intracranial artery, which is suitable to PTA and stenting based on the decision of the treating physician.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
DeviceRescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure.
• Technical success defined as successful recanalization of the occluded vessel (expanded treatment in cerebral ischemia score (eTICI) of 2b-3) at the end of the procedure.
Time frame
Assessed at the end of the treatment procedure.2
Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure.
• Good clinical outcome 90 (± 20) days after stroke defined as a score of 0-2 on the modified Ranking Scale (mRS 0-2).
Time frame
90 (± 20) days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov