European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke (PROMISE)
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|ClinicalTrials.gov Identifier: NCT02678169|
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment|
|Ischemic Stroke||Device: Penumbra Aspiration System|
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.
|Study Type :||Observational|
|Actual Enrollment :||204 participants|
|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|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Penumbra Aspiration System
Penumbra Aspiration System with the ADAPT technique
Device: Penumbra Aspiration System
Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain
- Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score. [ Time Frame: Immediate post-procedure ]
- Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2. [ Time Frame: 90 days post-procedure ]
- Incidence of device and procedure related Serious Adverse Events (SAEs) at 24 hours and 30 days from stroke treatment [ Time Frame: 24 hours and 30 days from stroke treatment ]
- All causes of mortality and morbidity at 90 days [ Time Frame: 90 days ]
- Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure [ Time Frame: At the end of interventional surgical procedure ]
- Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours [ Time Frame: 24 hours ]
- Occurrence of vessel damages at the end of the ADAPT procedure. [ Time Frame: At the end of the interventional surgical procedure ]
- NIHSS score at 7-10 days post-procedure. [ Time Frame: 7-10 days post-procedure ]
- Times to revascularization [ Time Frame: From symptom onset to various times during the interventional surgical procedure ]
- From symptom onset to CT-scan/MRI at the institution
- From CT-scan/MRI at the institution to groin access
- From groin puncture to final revascularization result.
- Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure. [ Time Frame: 90 days ]
- Heath Economics: Total duration of hospitalization with related healthcare resources [ Time Frame: Average time frame 3-7 days. ]
- Health care professionals encountered/consulted before/after intervention
- Tests performed before/after intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678169
|Lübeck, Germany, 23538|
|Principal Investigator:||Peter Schramm, MD||Universitätsklinikum Schleswig-Holstein, Lübeck, Germany|