Trial Outcomes & Findings for Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp) (NCT NCT02437409)

NCT ID: NCT02437409

Last Updated: 2017-08-23

Results Overview

modified Rankin Scale (mRS) Neurological Condition is measured by the "Modified Rankin Scale (mRS)". This scale ranges from 0 - 6: 0 = No symptoms at all; 1. = able to carry out all usual duties and activities; 2. = unable to carry out all previous activities, but able to look after own affairs without assistance; 3. = requiring some help, but able to walk without assistance; 4. = unable to walk without assistance and unable to attend to own bodily needs without assistance; 5. = bedridden, incontinent and requiring constant nursing care and attention; 6. = dead

• Recruitment status: COMPLETED
• Target enrollment: 115 participants
• Primary outcome timeframe: 90 days after treatment
• Results posted on: 2017-08-23

Participant Flow

115 patients started the study, but little by little, 15 patients were excluded/discontinued due to screening failure or withdrawn consent.

No assignment to groups was performed due to single-arm study.

Participant milestones

Measure	All Patients Treated with pREset Thrombectomy Retriever
Overall Study STARTED	115
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	All Patients Treated with pREset Thrombectomy Retriever
Overall Study Withdrawal by Subject	3
Overall Study Screening failure	12

Baseline Characteristics

Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp)

Baseline characteristics by cohort

Measure	All Patients n=100 Participants Treated with pREset Thrombectomy Retriever
Age, Continuous	68.3 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment Germany	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days after treatment

Population: All Patients

modified Rankin Scale (mRS)

Neurological Condition is measured by the "Modified Rankin Scale (mRS)". This scale ranges from 0 - 6:

0 = No symptoms at all;

1. = able to carry out all usual duties and activities;

2. = unable to carry out all previous activities, but able to look after own affairs without assistance;

3. = requiring some help, but able to walk without assistance;

4. = unable to walk without assistance and unable to attend to own bodily needs without assistance;

5. = bedridden, incontinent and requiring constant nursing care and attention;

6. = dead

Outcome measures

Measure	All Patients n=100 Participants Treated with pREset Thrombectomy Retriever
Neurological Condition of the Patient mRS 0	23 patients
Neurological Condition of the Patient mRS 0-1	52 patients
Neurological Condition of the Patient mRS 0-2	60 patients
Neurological Condition of the Patient mRS 3-5	29 patients
Neurological Condition of the Patient mRS 6	7 patients
Neurological Condition of the Patient Lost to follow-up	4 patients

SECONDARY outcome

Timeframe: 24 to 72 hr after treatment

Population: All Patients

The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are:

1. Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2)

2. Best Gaze (0-2)

3. Visual (0-3)

4. Facial palsy (0-3)

5. Motor arm (0-4)

6. Motor leg (0-4)

7. Limb ataxia (0-2)

8. Sensory (0-2)

9. Best Language (0-3)

10. Dysarthria (0-2)

11. Extinction and Inattention (0-2)

CLASSIFICATION:

0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke

As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale.pdf

Outcome measures

Measure	All Patients n=100 Participants Treated with pREset Thrombectomy Retriever
Neurological Condition of the Patient	5 NIHSS score Interval 0.0 to 42.0

SECONDARY outcome

Timeframe: 24 hr after treatment

Population: All Patients

Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites.

Outcome measures

Measure	All Patients n=100 Participants Treated with pREset Thrombectomy Retriever
Intracranial Hemorrhage (ICH)	14 patients

SECONDARY outcome

Timeframe: during intervention, up to 3 hr

Population: All Patients

Outcome measures

Measure	All Patients n=100 Participants Treated with pREset Thrombectomy Retriever
Time From Groin Puncture to Recanalization	40 minutes Interval 6.0 to 159.0

SECONDARY outcome

Timeframe: at the end of intervention, up to 3 hr

Population: 100 patients harboured 109 vessel occlusions

original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging.

Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion.

Outcome measures

Measure	All Patients n=109 vessel occlusions Treated with pREset Thrombectomy Retriever
Recanalization of the Target Vessel TICI 0	7 number of vessels
Recanalization of the Target Vessel TICI 1	2 number of vessels
Recanalization of the Target Vessel TICI 2a	8 number of vessels
Recanalization of the Target Vessel TICI 2b	40 number of vessels
Recanalization of the Target Vessel TICI 3	52 number of vessels

SECONDARY outcome

Timeframe: during intervention, up to 3 hr

Population: 100 patients harboured 109 vessel occlusions

Outcome measures

Measure	All Patients n=109 vessel occlusions Treated with pREset Thrombectomy Retriever
No. of Passages Needed to Reach the Final TICI Score With pREset	1.7 passes Standard Deviation 0.96

Adverse Events

All Patients

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients n=100 participants at risk Treated with pREset Thrombectomy Retriever
Injury, poisoning and procedural complications Mortality	7.0% 7/100 • Number of events 7 • 90 days after procedure

Other adverse events

Measure	All Patients n=100 participants at risk Treated with pREset Thrombectomy Retriever
Vascular disorders Extravasation	2.0% 2/100 • Number of events 2 • 90 days after procedure
Vascular disorders Vasospasm	3.0% 3/100 • Number of events 3 • 90 days after procedure
Vascular disorders Emboli to a new territory	2.0% 2/100 • Number of events 2 • 90 days after procedure
Vascular disorders Emboli to the same territory	3.0% 3/100 • Number of events 3 • 90 days after procedure
Vascular disorders Focal subarachnoid hemorrhages around the target vessel	7.0% 7/100 • Number of events 7 • 90 days after procedure
Vascular disorders PH I	4.0% 4/100 • Number of events 4 • 90 days after procedure
Vascular disorders PH II	3.0% 3/100 • Number of events 3 • 90 days after procedure

Additional Information

Clinical Affairs

phenox GmbH

Phone: +49 (0)234 36 919

Email: ARTESp@phenox.info

Results disclosure agreements

• Principal investigator is a sponsor employee Data must only be published after completion of the study. Publication of e.g. single center experience within the study is not allowed until the aggregate data have been submitted. All information and data generated in association with this study will be held in strict confidence and remain in the sole property of phenox GmbH. The investigator agrees to use this information for the sole purpose of completing this study and for no other purpose without written consent from phenox GmbH.
• Publication restrictions are in place

Restriction type: OTHER