European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke (PROMISE)

Penumbra

Status: Completed

Conditions: Ischemic Stroke

Treatments: Device: Penumbra Aspiration System

Study type: Observational

Funder types: Industry

Identifiers

NCT02678169

CLP 9508

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

204 participants in 1 patient group

Penumbra Aspiration System

Description:

Penumbra Aspiration System with the ADAPT technique

Treatment:

Device: Penumbra Aspiration System