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

Recruiting

Phase 4 Results N/A

Trial 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.

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.

Conditions

Interventions

  • Penumbra Aspiration System Device
    Intervention Desc: Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain
    ARM 1: Kind: Experimental
    Label: Penumbra Aspiration System
    Description: Penumbra Aspiration System with the ADAPT technique

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial 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)

Outcomes

Type Measure Time Frame Safety Issue
Primary Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score. Immediate post-procedure No
Primary Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2. 90 days post-procedure No
Secondary Incidence of device and procedure related Serious Adverse Events (SAEs) at 24 hours and 30 days from stroke treatment 24 hours and 30 days from stroke treatment Yes
Secondary All causes of mortality and morbidity at 90 days 90 days Yes
Secondary Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure At the end of interventional surgical procedure Yes
Secondary Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours 24 hours Yes
Secondary Occurrence of vessel damages at the end of the ADAPT procedure. At the end of the interventional surgical procedure Yes
Secondary NIHSS score at 7-10 days post-procedure. 7-10 days post-procedure No
Secondary Times to revascularization From symptom onset to various times during the interventional surgical procedure No
Secondary Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure. 90 days No
Secondary Heath Economics: Total duration of hospitalization with related healthcare resources Average time frame 3-7 days. No

Sponsors