Ischemic StrokeREDIRECTNCT01983644
RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study
A study testing RECO flow restoration device and Solitaire FR flow restoration device in people with Ischemic Stroke, run by Jinling Hospital, China at 10 sites in China.
Trial summary
Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with Solitaire FR within 8 hours of stroke onset caused by the large vessel occlusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- RECO flow restoration device and Solitaire FR flow restoration device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 10 sitesChina
- Study dates
- Sep 2013to Dec 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age (18-80 years)
- acute ischemic stroke
- within 8 hours after symptom onset
- a large-vessel confirmed by CTA/MRA (eg, internal carotid, middle cerebral M1 and/or M2 segments)
- NIHSS(≥8 and ≤24)
- patients or their legally authorised representatives provided signed, informed consent.
Who cannot join
- CT or MRI evidence of intracranial haemorrhage/tumor
- major ischaemic infarction (acute ischaemic change in more than a third of the middle cerebral artery territory)
- NIHSS(≥25 and ≤7)
- severe sustained hypertension (systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg)
- baseline glucose concentrations of less than 2·7 mmol/L or higher than 21.6 mmol/L
- known haemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with an international normalised ratio of more than 1.7
Show all 9Show fewer
- treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal, baseline platelet count of less than 100×10^9/L
- history of severe allergy (worse than rash) to contrast medium or nitinol
- pregnancy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
First People's Hospital of Changzhou
Changzhou, Jiangsu
Daping Hospital
Chongqing, Chongqing Municipality
Fuzhou General Hospital
Fuzhou, Fujian
Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Affiliated Hospital of Qingdao University
Qingdao, Shandong
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Zhongshan Hospital of Xiamen University
Xiamen, Fujian
Yangzhou First People's Hospital
Yangzhou, Jiangsu
About this study
Official title: RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study: a Prospective Randomised Control Trial(REDIRECT)
Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with Solitaire FR within 8 hours of stroke onset caused by the large vessel occlusion.
Read the detailed description
RECO is a novel, self-expanding stent retriever, designed to yield rapid flow restoration in acute cerebral ischaemia. The proposed study is a multicenter, randomized, prospective, parallel-group, open-label clinical trial with a blinded outcome, to test the RECO(a novel, self-expanding stent retriever), as compared with Solitaire FR stent retriever.
- Conditions
- Ischemic Stroke
- Being tested
- RECO flow restoration device, Solitaire FR flow restoration device
- Keywords
- acute ischemic stroke,endovascular recanalization, 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.
RECO flow restoration deviceDevice
Also called RECO
RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
Solitaire FR flow restoration deviceDevice
Also called Solitaire FR
Solitaire FR flow restoration device has been approved by the FDA and CFDA.
| Study group | Role | What they receive |
|---|---|---|
| RECO thrombectomy | Experimental | IA thrombectomy is executed by RECO flow restoration device which is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. Receives: Device: RECO flow restoration device |
| Solitaire FR thrombectomy | Active comparator | IA thrombectomy is executed by Solitaire FR flow restoration device Receives: Device: Solitaire FR flow restoration device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revascularization Status
Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower . Grade 3:Complete Perfusion.
Measured: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Secondary outcomes (3)
Clinical Outcomes at 90 Days
Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms.
Measured: 90-day
intracranial hemorrhages
Incidence of intracranial hemorrhages(ICH) within 24(-6/+12)hours post procedure
Measured: 24 hours
all-cause mortality at 90 days
Measured: procedure through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinfeng Liu, Jinling Hospital, China
- Investigators
- Xinfeng Liu, MD, Study chair, Department of Neurology, Jinling Hospital, Nanjing 210002, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983644
- Sponsor's protocol ID
- REDIRECT
- Acronym
- REDIRECT
- Status last verified
- Dec 2016
- First submitted
- 4 Nov 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cao J, Lin H, Lin M, Ke K, Zhang Y, Zhang Y, Zheng W, Chen X, Wang W, Zhang M, Xuan J, Peng Y; REDIRECT Trial Investigators. RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial. J Neurosurg. 2020 Jun 5;134(5):1569-1577. doi: 10.3171/2020.3.JNS193356. Print 2021 May 1.
PubMed 32502991Jiang Y, Li Y, Xu X, Yu Y, Liu W, Liu X. An in vitro porcine model evaluating a novel stent retriever for thrombectomy of the common carotid artery. Catheter Cardiovasc Interv. 2016 Feb 15;87(3):457-64. doi: 10.1002/ccd.26285. Epub 2015 Oct 30.
PubMed 26514251
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study: a Prospective Randomised Control Trial(REDIRECT)
- ClinicalTrials.gov ID
- NCT01983644
- Acronym / sponsor ID
- REDIRECT / REDIRECT
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke,endovascular recanalization, mechanical thrombectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Nov 2013 (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.
Endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.This study will compare the efficacy and safety of RECO(a novel, self-expanding stent retriever) with Solitaire FR within 8 hours of stroke onset caused by the large vessel occlusion.
Detailed description
RECO is a novel, self-expanding stent retriever, designed to yield rapid flow restoration in acute cerebral ischaemia. The proposed study is a multicenter, randomized, prospective, parallel-group, open-label clinical trial with a blinded outcome, to test the RECO(a novel, self-expanding stent retriever), as compared with Solitaire FR stent retriever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RECO thrombectomy | Experimental | Device: RECO flow restoration deviceIA thrombectomy is executed by RECO flow restoration device which is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. |
| Solitaire FR thrombectomy | Active comparator | Device: Solitaire FR flow restoration deviceIA thrombectomy is executed by Solitaire FR flow restoration device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age (18-80 years)
- acute ischemic stroke
- within 8 hours after symptom onset
- a large-vessel confirmed by CTA/MRA (eg, internal carotid, middle cerebral M1 and/or M2 segments)
- NIHSS(≥8 and ≤24)
Key exclusion criteria (9 listed)
- CT or MRI evidence of intracranial haemorrhage/tumor
- major ischaemic infarction (acute ischaemic change in more than a third of the middle cerebral artery territory)
- NIHSS(≥25 and ≤7)
- severe sustained hypertension (systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg)
- baseline glucose concentrations of less than 2·7 mmol/L or higher than 21.6 mmol/L
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 |
|---|---|---|
| RECO flow restoration deviceAlso: RECORECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. | Device | RECO thrombectomy |
| Solitaire FR flow restoration deviceAlso: Solitaire FRSolitaire FR flow restoration device has been approved by the FDA and CFDA. | Device | Solitaire FR thrombectomy |
Primary outcome
Revascularization Status
Time frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized. Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower . Grade 3:Complete Perfusion.
3 secondary outcomes
Clinical Outcomes at 90 Days
Time frame: 90-day
intracranial hemorrhages
Time frame: 24 hours
all-cause mortality at 90 days
Time frame: procedure through 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 32502991Cao J, Lin H, Lin M, Ke K, Zhang Y, Zhang Y, Zheng W, Chen X, Wang W, Zhang M, Xuan J, Peng Y; REDIRECT Trial Investigators. RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial. J Neurosurg. 2020 Jun 5;134(5):1569-1577. doi: 10.3171/2020.3.JNS193356. Print 2021 May 1.
- Derived from this study: PubMed 26514251Jiang Y, Li Y, Xu X, Yu Y, Liu W, Liu X. An in vitro porcine model evaluating a novel stent retriever for thrombectomy of the common carotid artery. Catheter Cardiovasc Interv. 2016 Feb 15;87(3):457-64. doi: 10.1002/ccd.26285. Epub 2015 Oct 30.
- Individual participant dataSharing planned: Undecided
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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.
Xinfeng Liu, MD study chair
Department of Neurology, Jinling Hospital, Nanjing 210002, China
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECO flow restoration device and Solitaire FR flow restoration device in people with Ischemic Stroke, run by Jinling Hospital, China at 10 sites in China.
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 6 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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?
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?
Revascularization Status (time frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment). 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 NCT01983644, which also lists 2 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 26 Jul 2018.