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

NCT03955835 | Terminated DMC

• 1 other identifier: ACUTE
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Acute Ischemic Stroke; Intracranial Stenosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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 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 Outcomes (2)

• Secondary Efficacy Endpoints

  90 +/- 10 days after stroke

• Secondary Safety Endpoints

  90 +/- 10 days after stroke

Study Arms (1)

ACUTE

OTHER

Patients with acute ischemic stroke and proven large vessel occlusion (e.g. intracranial internal carotid artery or middle cerebral artery) with unsuccessful recanalization after endovascular treatment with mechanical thrombectomy and suspected underlying stenosis of the occluded intracranial artery amenable to stenting based on judgment by the treating neurointerventionalist.

Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.

Interventions

Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter. DEVICE

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.

ACUTE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acandis GmbH: lead

Study Sites (8)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie

Hamburg, 22763, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes

Homburg, 66424, Germany

Location

Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie

Mönchengladbach, 41063, Germany

Location

Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg

Oldenburg, 26122, Germany

Location

Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik

Osnabrück, 49028, Germany

Location

Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik

Solingen, 42697, Germany

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, interventional treatment, single-arm, open-label, multi-centre trial

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: August 9, 2019
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)