CClinicalTrials.gg
RecruitingNCT05345483RECHRUTUpdated Dec 5, 2024

REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)

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

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
153
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rescue Stenting
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study 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.

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
153 participants (estimated)
Patient registry
No

Interventions

  • DeviceRescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter

    Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter

06

What researchers measure

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.

07

Study locations

17 of 17 sites recruiting
  • Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau
    Aschaffenburg, 63739, Germany
    Recruiting
  • Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg
    Augsburg, 86156, 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, 01307, Germany
    Recruiting
  • Klinik für Radiologie und Neuroradiologie, Sana Klinikum
    Duisburg, Germany
    Recruiting
  • Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt
    Erfurt, 99089, Germany
    Recruiting
  • Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle
    Halle (Saale), 06120, Germany
    Recruiting
  • Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona
    Hamburg, Germany
    Recruiting
  • Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
    Hamburg, Germany
    Recruiting
  • Radiologie / Neuroradiologie, Askleopis Klinik St. Georg
    Hamburg, Germany
    Recruiting
  • Klinik für Neuroradiologie, Westpfalz-Klinikum
    Kaiserslautern, Germany
    Recruiting
  • Abteilung für Radiologie und Nuklearmedizin, Sana Kliniken
    Lübeck, Germany
    Recruiting
  • Interventionelle Neuroradiologie, Universitätsklinikum Münster
    Münster, Germany
    Recruiting
  • Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
    Oldenburg, 26122, Germany
    Recruiting
  • Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest
    Recklinghausen, Germany
    Recruiting
  • Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum
    Solingen, 42653, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05345483
Lead sponsor
Acandis GmbH
Responsible party
Sponsor
First posted
Apr 26, 2022
Start date
Jan 25, 2023
Primary completion
Sep 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Dec 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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