Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)

Acute Ischemic Stroke Clinical Trial

— ACUTE  

Official title:

Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03955835
• Other study ID #: ACUTE
• Status: Terminated
• Phase: N/A
• Start date: August 9, 2019
• Est. completion date: September 22, 2021

Study information

• Verified date: October 2021
• Source: Acandis GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study objective 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® stent together with the NeuroSpeed® PTA balloon catheter.

Description:

Prospective, interventional treatment, single-arm, open-label, multi-center trial.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: September 22, 2021
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Acute ischemic stroke from large vessel occlusion (LVO)

• Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion of intracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middle cerebral artery (MCA) (TICI 0-1)

• Small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion < 70 ml)

• Suspected underlying stenosis of the occluded artery amenable to stenting by judgement of the treating neurointerventionalist

• Age 18- 80 years

• Informed consent (see below)

• Decision to perform angioplasty and stenting < 12 hours of symptom onset

• Previous passage of occlusion with microcatheter obtained

Exclusion Criteria:

• Large infarct core prior to initiation of thrombectomy (CT ASPECTS 0-5, DWI lesion > 70 ml)

• Vessel occlusion or stenosis of different known or suspected cause than atherosclerosis (e.g. vasculitis)

• Pre-stroke disability (MRS > 2)

• Any sign of intracranial haemorrhage on brain imaging prior to thrombectomy

• Any sign of intracranial vessel perforation during thrombectomy

• Contraindication against treatment with double anti-platelet treatment

• Current effective use of oral anticoagulants (e.g. INR > 1.7 for Vitamin K antagonists)

• More than 3 attempts for recanalization of target lesion prior to the use of the study device.

• Stenosis longer than the working length of the NeuroSpeed PTA balloon catheter.

• Diameter of the healthy vessel proximal and distal to the stenosis prevents save treatment with the NeuroSpeed PTA balloon catheter or is outside the indicated range of the Credo stent.

• Diameter of the target area is outside the indicated range of the Credo stent after predilation.

• Contraindication against anti-platelet or anticoagulation therapy

• Heavily calcified lesions that may prevent access or safe stent placement.

• Pregnant and breastfeeding women

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Intracranial Stenosis
• Ischemic Stroke

Intervention

Device:
• Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.
Self-expandable Credo® stent together with NeuroSpeed® PTA balloon catheter. Credo® and NeuroSpeed® are already CE approved products, for which within ACUTE an additional new indication shall be examined.

Locations

Country	Name	City	State
Germany	Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes	Homburg
Germany	Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie	Mönchengladbach
Germany	Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg	Oldenburg
Germany	Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik	Osnabrück
Germany	Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik	Solingen

Sponsors (1)

Lead Sponsor	Collaborator
Acandis GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Co-Primary Technical Efficacy Endpoint	Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting).	Assessed after interventional procedure
Primary	Co-Primary Clinical Efficacy Endpoint	Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2).	90 +/- 10 days after stroke
Primary	Primary Safety Endpoints	Symptomatic intracranial hemorrhage (SICH) as defined in SITS-MOST (within 18-36 hours of treatment); Device-related procedural complications: Dissection, perforation or rupture of the target vessel, embolism, stent thrombosis or occlusion, stent migration.	Within 18-36 hours after treatment
Secondary	Secondary Efficacy Endpoints	Categorical shift in MRS 90 (±10) days after stroke; Functional health status and quality of life 90 (±10) days after stroke (EQ-5D); Infarct growth by 18-36 hours after stroke as compared to predicted infarct growth; Frequency of residual stenosis > 50 %	90 +/- 10 days after stroke
Secondary	Secondary Safety Endpoints	Ischemic stroke in downstream territory of the occluded vessel within 90 (±10) days after stroke; Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours; Embolization in new territories; Mortality 90 (±10) days after stroke; Death or dependency 90 (±10) days after stroke (MRS 4-6)	90 +/- 10 days after stroke