Back to results

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

Primary Purpose

Acute Ischemic Stroke, Intracranial Stenosis

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ACUTE

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

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).

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.

Secondary Outcome Measures

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 %

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)

Full Information

NCT ID

NCT03955835

First Posted

May 16, 2019

Last Updated

October 14, 2021

Sponsor

Acandis GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03955835

Brief Title

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

Acronym

ACUTE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

CREDO stent is now CE-marked for rescue stenting (new indication).

Study Start Date

August 9, 2019 (Actual)

Primary Completion Date

September 22, 2021 (Actual)

Study Completion Date

September 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acandis GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke, Intracranial Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACUTE

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Co-Primary Technical Efficacy Endpoint

Description

Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting).

Time Frame

Assessed after interventional procedure

Title

Co-Primary Clinical Efficacy Endpoint

Description

Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2).

Time Frame

90 +/- 10 days after stroke

Title

Primary Safety Endpoints

Description

Time Frame

Within 18-36 hours after treatment

Secondary Outcome Measure Information:

Title

Secondary Efficacy Endpoints

Description

Time Frame

90 +/- 10 days after stroke

Title

Secondary Safety Endpoints

Description

Time Frame

90 +/- 10 days after stroke

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Universitätsklinikum Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie

City

Hamburg

ZIP/Postal Code

22763

Country

Germany

Facility Name

Universitätsklinikum Heidelberg

City

Heidelberg

Country

Germany

Facility Name

Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes

City

Homburg

ZIP/Postal Code

66424

Country

Germany

Facility Name

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

City

Mönchengladbach

ZIP/Postal Code

41063

Country

Germany

Facility Name

Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik

City

Osnabrück

ZIP/Postal Code

49028

Country

Germany

Facility Name

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

City

Solingen

ZIP/Postal Code

42697

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs