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

Ischemic Stroke Clinical Trial

— PROMISE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678169
• Other study ID #: CLP 9508
• Status: Completed
• Phase: N/A
• First received: January 27, 2016
• Last updated: January 16, 2018
• Start date: February 2016
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Penumbra Aspiration System
Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	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
Primary	Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2.		90 days post-procedure
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
Secondary	All causes of mortality and morbidity at 90 days		90 days
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
Secondary	Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours		24 hours
Secondary	Occurrence of vessel damages at the end of the ADAPT procedure.		At the end of the interventional surgical procedure
Secondary	NIHSS score at 7-10 days post-procedure.		7-10 days post-procedure
Secondary	Times to revascularization	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.	From symptom onset to various times during the interventional surgical procedure
Secondary	Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure.		90 days
Secondary	Heath Economics: Total duration of hospitalization with related healthcare resources	Health care professionals encountered/consulted before/after intervention; Tests performed before/after intervention.	Average time frame 3-7 days.