Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp) "ARTESp"
Completed
Phase N/A ResultsUpdate History
10 Nov '15 |
The description was updated. New
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.
Old
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.
The eligibility criteria were updated. New
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
Old
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, A. media
, anterior cerebral artery, basilar artery, vertebral artery, posterior cerebral
artery).
- NIHSS ≥ 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
- NHISS > 30
- Anticoagulation with warfarin with INR (international normalized ratio) > 3.0,
- Platelets <30,000,
- Glucose <50mg/dl,
- Life expectancy <90 days
|
28 May '15 |
Trial name was updated. New Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp) A location was updated in Stuttgart. New The overall status was removed for Katharinenhospital. A location was updated in München. New The overall status was removed for Klinikum rechts der Isar. A location was updated in Münster. New The overall status was removed for Universitätsklinikum Münster. A location was updated in Homburg. New The overall status was removed for Universitätsklinikum des Saarlandes. |
View Trial Locations
Recruitment
- Enrollment: 100
- Gender: Both
- Minimum Age: 18 Years
- Accepts Healthy Volunteers: No
- 4 locations, 1 country
Principal Investigator
- Wolfgang Reith, Prof.
nrreith@uks.eu +49 6841 16