Evaluating stenting for patients with unsuccessful thrombectomy in stroke treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of using the CREDO® Heal Stent for acute permanent stenting in patients who have experienced unsuccessful recanalization by thrombectomy due to symptomatic intracranial stenosis. It focuses on individuals with acute ischemic stroke caused by large vessel occlusion, where alternative therapies have failed or are not viable. The intervention involves the use of the CREDO® Heal Stent in conjunction with a NeuroSpeed PTA Balloon Catheter following at least one failed mechanical recanalization attempt. The study will evaluate outcomes related to the procedure's effectiveness and safety in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* With small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion \< 70 ml)
* With symptoms onset less than 24 hours before start of the procedure
* Treated with study device following at least one futile mechanical recanalization attempt with a stent retriever, direct aspiration or combination of both
* With pre-stroke disability mRS 0-2

Exclusion Criteria:

* Any contraindication according to IFU and patients:
* 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

Where it's running

• Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau
  Aschaffenburg, Germany Recruiting
• Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg
  Augsburg, Germany Recruiting
• Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn
  Bonn, Germany Recruiting
• Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide
  Bremerhaven, Germany Recruiting
• Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden
  Dresden, Germany Recruiting
• Klinik für Radiologie und Neuroradiologie, Sana Klinikum
  Duisburg, Germany Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.