Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

Acute Stroke Clinical Trial

— ReFlow  

Official title:

Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke (ReFlow Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210729
• Other study ID #: ReFlow01
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2010
• Last updated: December 1, 2011
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: September 2010
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to collect data on the use of the SOLITAIR FR device for treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether the application of SOLITAIR is a safe and feasible method for interventional recanalization of large vessels with favorable patient outcome in acute stroke therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 18-85 years

• Acute ischemic stroke with occlusion if ICA, MCA, VA or BA (TICI 0 or 1 flow) within the first 6 hours

Exclusion Criteria:

• Rapidly improving neurological signs

• NHISS>30 or coma

• Female patients, who are pregnant or lactating

• Use of warfarin anticoagulation with INR > 1.5

• Platelet count < 30,000

• Glucose < 50 mg/dL

• Life expectancy of less than 90 days

• Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation

• CT showing hypodensity on presentation

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Device:
• Solitaire FR, ev3
Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.

Locations

Country	Name	City	State
Germany	Department of diagnostic and interventional Neuroradiology	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Papanagiotou P, Roth C, Reith W. Letter by Papanagiotou et Al regarding article, "percutaneous vascular interventions for acute ischemic stroke". Stroke. 2011 Sep;42(9):e545; author reply e546. doi: 10.1161/STROKEAHA.111.620989. Epub 2011 Jul 14. — View Citation

Papanagiotou P, Roth C, Walter S, Behnke S, Grunwald IQ, Viera J, Politi M, Körner H, Kostopoulos P, Haass A, Fassbender K, Reith W. Carotid artery stenting in acute stroke. J Am Coll Cardiol. 2011 Nov 29;58(23):2363-9. doi: 10.1016/j.jacc.2011.08.044. — View Citation

Papanagiotou P, Roth C, Walter S, Behnke S, Politi M, Fassbender K, Haass A, Reith W. Treatment of acute cerebral artery occlusion with a fully recoverable intracranial stent: a new technique. Circulation. 2010 Jun 15;121(23):2605-6. doi: 10.1161/CIRCULATIONAHA.110.948166. — View Citation

Roth C, Papanagiotou P, Behnke S, Walter S, Haass A, Becker C, Fassbender K, Politi M, Körner H, Romann MS, Reith W. Stent-assisted mechanical recanalization for treatment of acute intracerebral artery occlusions. Stroke. 2010 Nov;41(11):2559-67. doi: 10.1161/STROKEAHA.110.592071. Epub 2010 Oct 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6)		Day 90	No
Secondary	Arterial recanalization of occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI)score of 2b or 3 following the use of the SOLITAIRE FR Device		Day 0	No
Secondary	Excellent functional clinical outcome (modified Rankin Scale 0 or 1)		Day 90	No
Secondary	All causes of mortality		Day 90	Yes
Secondary	Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after treatment.		Day 1	No
Secondary	Symptomatic intracranial haemorrhages up to 24 hours after treatment defined as homogeneous areas of haemorrhage, with or without mass effect or intraventricular extension with neurological deterioration		Day 1	Yes
Secondary	Time between arterial puncture and Flow Restoration		Day 0	No
Secondary	Time between arterial puncture and TICI 2b or 3 recanalization		Day 0	No
Secondary	Number of SOLITAIRE device runs until recanalization		Day 0	No
Secondary	Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE		Day 90	No
Secondary	Number of patients in which thrombus material was preserved		Day 0	No
Secondary	Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome		Day 1	No
Secondary	Overall frequency of modified Rankin Scale 0 to 2 at 30 days		Day 30	No