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Acute StrokePhase 2ReFlowNCT01210729

Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke

A Phase 2 study testing Solitaire FR, ev3 in people with Acute Stroke, run by Universität des Saarlandes at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Stroke
What is being tested?
Solitaire FR, ev3
Type of treatment
Medical device
How many people
40 participants
Where
1 siteGermany
Study dates
Sep 2010to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of diagnostic and interventional Neuroradiology

    Homburg, Saarland, 66424

Other trials in Germany

About this study

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

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.

Conditions
Acute Stroke
Being tested
Solitaire FR, ev3
Keywords
stroke, mechanical recanalization, self-expanding stent, Solitaire
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solitaire FR, ev3Device

    Also called device used: Solitaire FR, ev3, USA

    Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6)

    Measured: Day 90

Secondary outcomes (12)

  1. 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

    Measured: Day 0

  2. Excellent functional clinical outcome (modified Rankin Scale 0 or 1)

    Measured: Day 90

  3. All causes of mortality

    Measured: Day 90

  4. Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after treatment.

    Measured: Day 1

  5. 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

    Measured: Day 1

  6. Time between arterial puncture and Flow Restoration

    Measured: Day 0

  7. Time between arterial puncture and TICI 2b or 3 recanalization

    Measured: Day 0

  8. Number of SOLITAIRE device runs until recanalization

    Measured: Day 0

  9. Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE

    Measured: Day 90

  10. Number of patients in which thrombus material was preserved

    Measured: Day 0

  11. Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome

    Measured: Day 1

  12. Overall frequency of modified Rankin Scale 0 to 2 at 30 days

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01210729
Sponsor's protocol ID
ReFlow01
Acronym
ReFlow
Status last verified
Sep 2010
First submitted
27 Sep 2010
Last updated
2 Dec 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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. No abstract available.

    PubMed 20547941

  • Roth C, Papanagiotou P, Behnke S, Walter S, Haass A, Becker C, Fassbender K, Politi M, Korner 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.

    PubMed 20947848

  • Papanagiotou P, Roth C, Walter S, Behnke S, Grunwald IQ, Viera J, Politi M, Korner 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.

    PubMed 22115640

  • 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. No abstract available.

    PubMed 21757666

  • Roth C, Reith W, Walter S, Behnke S, Kettner M, Viera J, Yilmaz U, Alexandrou M, Politi M, Kostopoulos P, Korner H, Krick C, Haass A, Fassbender K, Papanagiotou P. Mechanical recanalization with flow restoration in acute ischemic stroke: the ReFlow (mechanical recanalization with flow restoration in acute ischemic stroke) study. JACC Cardiovasc Interv. 2013 Apr;6(4):386-91. doi: 10.1016/j.jcin.2012.11.013. Epub 2013 Mar 20.

    PubMed 23523460

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Solitaire FR, ev3 in people with Acute Stroke, run by Universität des Saarlandes at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6) (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01210729, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2011; AzTrials last refreshed its copy on 6 Nov 2026.

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