Clinical trial NCT02678169: European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
Official title: A Prospective, Multicenter, Observational, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-09
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Present with symptoms consistent with an acute ischemic stroke within 6 hours of stroke symptom onset. Arterial occlusion of the distal intracranial carotid artery (ICA and ICA terminus) or middle cerebral artery (M1/M2)

Brief summary: Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.

Detailed description: Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.

The follow-up visit will occur 24 hours, 7-10 days or discharge, 30 days and 90 days post-procedure and will review patient's functional outcome, quality of life, and adverse events.

Eligibility criteria: Inclusion Criteria:

* General inclusion criteria:

  * From 18 years of age
  * Present with symptoms consistent with an acute ischemic stroke within 6 hours of stroke symptom onset
  * Arterial occlusion of the distal intracranial carotid artery (ICA and ICA terminus) or middle cerebral artery (M1/M2)
  * National Institute of Health Stroke Scale (NIHSS) ≥ 2
  * Signed Informed Consent Form.

Imaging inclusion criteria:

• CT ASPECT score from 6 to 10 (\>6) or according to MR DWI ASPECT score from 5 to 10 (\>5).

Exclusion Criteria:

* General exclusion criteria:

  * Associated myocardial infarction or severe infection (endocarditis or sepsis)
  * Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) of \> 3.0 or platelets count \< 40 x109/L or APTT \> 50 sec
  * Uncontrolled hypertension (defined as systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg)
  * Baseline glucose \< 2.7 or \> 22.2 mmol/L
  * Pre-stroke mRS score \> 2
  * Seizure at the onset of stroke
  * Arterial tortuosity that would prevent the device from reaching the target vessel
  * Time of stroke symptoms onset unknown
  * Life expectancy less than 90 days prior to stroke onset
  * Females who are pregnant or lactating
  * Known serious sensitivity to radiographic contrast media.

Imaging exclusion criteria:

* CT/MRI evidence of the following conditions at screening:

  * Significant mass effect with midline shift
  * Evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM)
* Angiographic evidence of tandem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion criterion.
* Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.

Primary outcomes:
measure: Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score.
timeFrame: Immediate post-procedure
measure: Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2.
timeFrame: 90 days post-procedure
Secondary outcomes:
measure: Incidence of device and procedure related Serious Adverse Events (SAEs) at 24 hours and 30 days from stroke treatment
timeFrame: 24 hours and 30 days from stroke treatment
measure: All causes of mortality and morbidity at 90 days
timeFrame: 90 days
measure: Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
timeFrame: At the end of interventional surgical procedure
measure: Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
timeFrame: 24 hours
measure: Occurrence of vessel damages at the end of the ADAPT procedure.
timeFrame: At the end of the interventional surgical procedure
measure: NIHSS score at 7-10 days post-procedure.
timeFrame: 7-10 days post-procedure
measure: Times to revascularization
timeFrame: From symptom onset to various times during the interventional surgical procedure
measure: Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure.
timeFrame: 90 days
measure: Heath Economics: Total duration of hospitalization with related healthcare resources
timeFrame: Average time frame 3-7 days.
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
Study officials:
affiliation: Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
name: Peter Schramm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schramm P, Navia P, Papa R, Zamarro J, Tomasello A, Weber W, Fiehler J, Michel P, Pereira VM, Krings T, Gralla J, Santalucia P, Pierot L, Lo TH. ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study. J Neurointerv Surg. 2019 Mar;11(3):226-231. doi: 10.1136/neurintsurg-2018-014122. Epub 2018 Jul 30.
citation: Blanc R, Redjem H, Ciccio G, Smajda S, Desilles JP, Orng E, Taylor G, Drumez E, Fahed R, Labreuche J, Mazighi M, Lapergue B, Piotin M. Predictors of the Aspiration Component Success of a Direct Aspiration First Pass Technique (ADAPT) for the Endovascular Treatment of Stroke Reperfusion Strategy in Anterior Circulation Acute Stroke. Stroke. 2017 Jun;48(6):1588-1593. doi: 10.1161/STROKEAHA.116.016149. Epub 2017 Apr 20.