An observational study in Rescue Stenting, sponsored by Acandis GmbH. Recruiting at 17 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Acandis GmbH · Observational
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.
Acandis GmbH is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
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.
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.
Plan to share: No
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Acandis GmbH