Rescue StentingRECHRUTNCT05345483
REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
An observational study of Rescue Stenting, run by Acandis GmbH at 17 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rescue Stenting
- What is being tested?
- Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- 17 sitesGermany
- Study dates
- 25 Jan 2023to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Germany17 sites, 17 recruiting
- Recruiting
Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau
Aschaffenburg, 63739
PD Dr. med. Volker Maus, +49, info@acandis.com
- Recruiting
Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg
Augsburg, 86156
Prof. Dr. med. Ansgar Berlis, +49, info@acandis.com
- Recruiting
Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn
Bonn
Prof. Dr. med. Franziska Dorn, +49, info@acandis.com
- Recruiting
Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide
Bremerhaven
Dr. med. Timo Phung, +49, info@acandis.com
- Recruiting
Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden
Dresden, 01307
Dr. med. Johannes Gerber, +49, info@acandis.com
- Recruiting
Klinik für Radiologie und Neuroradiologie, Sana Klinikum
Duisburg
Dr. med. Martin Schlunz-Hendann, +49, info@acandis.com
- Recruiting
Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt
Erfurt, 99089
PD Dr. med. Donald Lobsien, +49, info@acandis.com
- Recruiting
Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle
Halle, 06120
PD Dr. med. Stefan Schob, +49, info@acandis.com
- Recruiting
Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona
Hamburg
Prof. Dr. med. Bernd Eckert, +49, info@acandis.com
- Recruiting
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
Hamburg
Dr. med. Maxim Bester, +49, info@acandis.com
- Recruiting
Radiologie / Neuroradiologie, Askleopis Klinik St. Georg
Hamburg
Dr. med. Jan-Hendrik Buhk, +49, info@acandis.com
- Recruiting
Klinik für Neuroradiologie, Westpfalz-Klinikum
Kaiserslautern
Dr. med. Andreas Simgen, +49, info@acandis.com
- Recruiting
Abteilung für Radiologie und Nuklearmedizin, Sana Kliniken
Lübeck
Dr. med. Christian Dyzmann, +49, info@acandis.com
- Recruiting
Interventionelle Neuroradiologie, Universitätsklinikum Münster
Münster
Dr. med. Christian-Paul Stracke, +49, info@acandis.com
- Recruiting
Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
Oldenburg, 26122
PD Dr. med. Christian Mathys, +49, info@acandis.com
- Recruiting
Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest
Recklinghausen
Dr. med. Christian Loehr, +49, info@acandis.com
- Recruiting
Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum
Solingen, 42653
Dr. med. Hannes Nordmeyer, PI, +49 212 547-2192, nordmeyer.hannes@klinikumsolingen.de
About this study
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.
- Conditions
- Rescue Stenting
- Being tested
- Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon CatheterDevice
Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 90 (± 20) days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start25 Jan 2023
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rescue StentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345483
- Sponsor's protocol ID
- RECHRUT
- Acronym
- RECHRUT
- Status last verified
- Dec 2024
- First submitted
- 7 Apr 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
- ClinicalTrials.gov ID
- NCT05345483
- Acronym / sponsor ID
- RECHRUT / RECHRUT
- Conditions
- Rescue Stenting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon CatheterRescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter | Device | – |
Primary outcome
Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure.
Time frame: Assessed 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.
Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure.
Time frame: 90 (± 20) days.
• Good clinical outcome 90 (± 20) days after stroke defined as a score of 0-2 on the modified Ranking Scale (mRS 0-2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Rescue Stenting
Recruiting
Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke
Acute Ischemic Stroke, Intracranial Atherosclerosis ICAS
RecruitingPhase 3
Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
Brain Stroke, Stenting Treatment
Active, not recruiting
Efficacy of Rescue Stenting/Angioplasty After Failed Thrombectomy for Acute Large Intracranial Vascular Occlusion
Acute Ischemic Stroke
RecruitingObservational study
Rescue Stenting and Intravenous Thrombolysis In Patients With Large Vessel Ischemic Stroke
Large Vessel Occlusion, Stroke Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau
Aschaffenburg, Germany
Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg
Augsburg, Germany
Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn
Bonn, Germany
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rescue Stenting, run by Acandis GmbH at 17 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure. (time frame: Assessed at the end of the treatment procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.