Ischemic StrokeARISENCT02533778
ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization
A study testing mechanical thrombectomy in people with Ischemic Stroke, run by Abington Memorial Hospital at 1 site in United States.
Trial summary
A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- mechanical thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 1 Jul 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or
- mechanical thrombectomy Vessels - intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or
- ACA NIHSS ≥ 7 MRI DWI/PWI or
- CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd
- Signed informed consent
Who cannot join
- creat >= 2
- NIHSS < 7
- Baseline mRS >= 2
- infarct > 1/3rd MCA territory
- competing trials
- prior IV or IA treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Abington Memorial Hospital
Abington, Pennsylvania, 19001
About this study
A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.
Read the detailed description
Ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or IV thrombolytic treatment and are screen with CT or MR perfusion imaging showing penumbra and infarction not > 1/3rd the territory.
- Conditions
- Ischemic Stroke
- Being tested
- mechanical thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical thrombectomyDevice
Also called Penumbra system, TREVO, Solitaire
Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device
| Study group | Role | What they receive |
|---|---|---|
| Interventional mechanical thrombectomy | Experimental | Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours Receives: Device: mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombolysis in Cerebral Infarction (TICI) score
Measured: 6 months
Secondary outcomes (3)
National Institutes of Health Stroke Scale (NIHSS) score
Measured: 6 months
Montreal Cognitive Assessment (MoCA) tool
Measured: 6 months
Modified Rankin Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Why it stopped: Similar large international competing trial with results of strong positive statistically benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- with control group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Bussinger, Abington Memorial Hospital
- Investigators
- Qaisar Shah, MD, Principal investigator, Abington Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533778
- Sponsor's protocol ID
- G140041
- Acronym
- ARISE
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2015
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization
- ClinicalTrials.gov ID
- NCT02533778
- Acronym / sponsor ID
- ARISE / G140041
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Similar large international competing trial with results of strong positive statistically benefit
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Abington Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.
Detailed description
Ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or IV thrombolytic treatment and are screen with CT or MR perfusion imaging showing penumbra and infarction not > 1/3rd the territory.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- with control group
| Arm | Type | Receives |
|---|---|---|
| Interventional mechanical thrombectomy | Experimental | Device: mechanical thrombectomyMechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or
- mechanical thrombectomy Vessels - intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or
- ACA NIHSS ≥ 7 MRI DWI/PWI or
- CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd
- Signed informed consent
Key exclusion criteria (6 listed)
- creat >= 2
- NIHSS < 7
- Baseline mRS >= 2
- infarct > 1/3rd MCA territory
- competing trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical thrombectomyAlso: Penumbra system, TREVO, SolitaireMechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device | Device | Interventional mechanical thrombectomy |
Primary outcome
Thrombolysis in Cerebral Infarction (TICI) score
Time frame: 6 months
3 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS) score
Time frame: 6 months
Montreal Cognitive Assessment (MoCA) tool
Time frame: 6 months
Modified Rankin Scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qaisar Shah, MD principal investigator
Abington Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical thrombectomy in people with Ischemic Stroke, run by Abington Memorial Hospital at 1 site in United States.
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 5 inclusion and 6 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: paused, as of the sponsor's last update on 2 Aug 2017. 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
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?
Thrombolysis in Cerebral Infarction (TICI) score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2017.