N/A
N=115
Acute Recanalization of Thrombo-Embolic Ischemic Stroke With pREset (ARTESp)
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02437409 ↗Enrolled (actual)
115
Serious AEs
7.0%
Results posted
Nov 2015
Primary outcome: Primary: Neurological Condition of the Patient — 23; 52; 60; 29 patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- pREset thrombectomy retriever (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Phenox GmbH
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurological Condition of the Patient |
5 | — |
| SECONDARY Neurological Condition of the Patient |
5 | — |
| SECONDARY Intracranial Hemorrhage (ICH) |
14 | — |
| SECONDARY Time From Groin Puncture to Recanalization |
40 | — |
| SECONDARY Recanalization of the Target Vessel |
7; 2; 8; 40; 52 | — |
| SECONDARY No. of Passages Needed to Reach the Final TICI Score With pREset |
1.7 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02437409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.