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

NCT02678169 | Completed DMC

• 1 other identifier: CLP 9508
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score.

  Immediate post-procedure

• Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2.

  90 days post-procedure

Secondary Outcomes (9)

• 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

• All causes of mortality and morbidity at 90 days

  90 days

• 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

• Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours

  24 hours

• Occurrence of vessel damages at the end of the ADAPT procedure.

  At the end of the interventional surgical procedure

Study Arms (1)

Penumbra Aspiration System

Penumbra Aspiration System with the ADAPT technique

Device: Penumbra Aspiration System

Interventions

Penumbra Aspiration System DEVICE

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

Penumbra Aspiration System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• 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.
• 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 preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Related Publications (2)

• 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.

  PMID: 30061367 DERIVED

• 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.

  PMID: 28428348 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Schramm, MD

  Universitätsklinikum Schleswig-Holstein, Lübeck, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)