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

Stroke Clinical Trial

— ARTESp  

Official title:

Akute Rekanalisation Eines ischämischen Schlaganfalls Mittels pREset

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437409
• Other study ID #: T01-072012
• Status: Completed
• Phase: N/A
• First received: April 28, 2015
• Last updated: October 7, 2015
• Start date: February 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Phenox GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox GmbH* Germany) will be examined. The effectiveness, safety and the long-term success when using the pREset to treat acute occlusions of cerebral vessels will be analyzed.

*German: "Gesellschaft mit beschränkter Haftung", limited liability company

Description:

ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox GmbH Germany) will be examined. The effectiveness, safety and the long-term success when using the pREset to treat acute occlusions of cerebral vessels will be analyzed.

In this study the market-approved, self-expandable stent retriever (pREset, phenox GmbH, Germany) will be used to achieve a direct flow recovery.

The thrombectomy system will be unfolded directly in the vessel occlusion. In a second step, the system and the thrombus will be pulled back into the guide catheter.

It is planned to enroll 100 patients at the age of 18 until 85 years, with a NIHSS (National Institutes of Health Stroke Scale) ≥ 8 and ≤ 30. The preconditions for study enrollment are the written consent of the patient or of the legal representative and the fulfillment of all mentioned inclusion and exclusion criteria. Pregnant women are excluded from study participation.The clinical interventions are in accordance with the clinical standard of care for the treatment of this patient population.

The mRS (Modified Rankin Scale) on day 30, the NIHSS on day 90 and an imaging procedure on day 90 may be performed by the study site provided that it corresponds to the clinical standards of the study site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient age = 18 and = 85 years.

• Patients with acute-onset stroke in the 0-6 hour time window for cerebral onset of symptoms and in angiography with a TICI reperfusion (Thrombolysis in Cerebral Infarction) value of 0 or 1 of at least one major cerebral artery (carotid artery, A. media , anterior cerebral artery, basilar artery, vertebral artery, posterior cerebral artery).

• NIHSS (National Institutes of Health Stroke Scale) = 8

• Signed Informed Consent by patient / legal representative to participate in the study.

Exclusion Criteria:

• Pregnancy

• Demarcated infarcted area in the initial Cranial CT or intracranial haemorrhage,

• Rapid improvement of neurological symptoms

• NIHSS > 30

• Anticoagulation with warfarin with INR (international normalized ratio) > 3.0,

• Platelets <30,000,

• Glucose <50mg/dl,

• Life expectancy <90 days

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• pREset thrombectomy retriever
Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA).

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes	Homburg	Saarland
Germany	Klinikum rechts der Isar	München	Bayern
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen
Germany	Katharinenhospital	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Phenox GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological Condition of the Patient	modified Rankin Scale (mRS) Neurological Condition is measured by the "Modified Rankin Scale (mRS). This scale ranges from 0 - 6, where 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	90 days after treatment	Yes
Secondary	Recanalization of the Target Vessel	Thrombolysis in Cerebral Infarction (TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. The scale ranges from 0-3, 3 being the best mark. 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.	immediately after treatment, an expected average of 1 hour	No
Secondary	Neurological Condition of the Patient	modified Rankin Scale (mRS) Neurological Condition is measured by the "Modified Rankin Scale (mRS). This scale ranges from 0 - 6, where 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	24 - 72 hr after treatment and at discharge (an expected average of 7 days)	No
Secondary	Neurological Condition of the Patient	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: Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2); Best Gaze (0-2); Visual (0-3); Facial palsy (0-3); Motor arm (0-4); Motor leg (0-4); Limb ataxia (0-2); Sensory (0-2); Best Language (0-3); Dysarthria (0-2); Extinction and Inattention (0-2)	24 hr after treatment	Yes
Secondary	Patient Safety	Intracranial Hemorrhage	24 hr after treatment	Yes
Secondary	Time From Groin Puncture to Recanalization		during treatment (an expected average of 1h)	No
Secondary	Recanalization of the Target Vessel	Thrombolysis in Cerebral Infarction (TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. The scale ranges from 0-3, 3 being the best mark. 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.	after final recanalization (an expected average of 1h)	No
Secondary	No. of Passages Needed to Reach the Final TICI Score With pREset		while treatment (an expected average of 1h)	No

External Links

•   phenox GmbH