RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial

Cao, Jie; H, Lin; Lin, Min; Ke, Kaifu; Zhang, Yunfeng; Zhang, Yong; Zheng, Weihong; Chen, Xingyu; Wang, Wei; Zhang, Meng; Xuan, Jinggang; Peng, Ya

doi:10.3171/2020.3.jns193356

Cited by 7 publications

(5 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Stent retriever has recently been widely used for thrombectomy, and has been reported to be associated with faster reperfusion and higher rate of successful recanalization in endovascular treatment of intracranial LVO (19). However, the research and development of domestic stent retrievers is relatively slow and few devices have been verified by clinical trials (15), which greatly hinders the progress of endovascular treatment in China. The purpose of this trial is to verify whether the new thrombectomy device-Skyflow has similar safety and efficacy compared with Solitaire FR in the treatment of acute LVO.…”

Section: Discussionmentioning

confidence: 99%

“…Compared with other stent retriever, the device-Skyflow has some unique structural features (15,20,21). The double helix structure makes stent have excellent flexibility and adhesion, which improve the thrombus removal rate, while avoid excessive damage for intracranial blood vessels.…”

Section: Discussionmentioning

confidence: 99%

“…In recent studies, the new mechanical thrombectomy devices, such as EmboTrap, Tigertriever and NeVa TM , have also achieved a high recanalization rate and good clinical outcome (9)(10)(11)(12). The safety and efficacy of the domestically-made mechanical thrombectomy devices, such as Tonbridge stent retriever, JRecan stent retriever, and Reco stent retriever, have been verified in animal experiments or clinical trials, but they have not yet been widely used (13)(14)(15). In China, stent retrievers are still mainly imported and are expensive, making a lot of patients unable to receive effective treatment.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Thrombectomy for Acute Ischemic Stroke With a New Device-Skyflow: Study Protocol for a Prospective, Multicenter, Stratified Randomized, Single-Blinded, Parallel, Positive Controlled, Non-inferiority Clinical Trial

Liu

Zhu

et al. 2021

Front. Neurol.

View full text Add to dashboard Cite

Background: Stent retriever thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in anterior circulation. The aim of the trial is to evaluate whether the new thrombectomy device-Skyflow can achieve the same safety and efficacy as Solitaire FR in the treatment.Method: This study is a prospective, multicenter, stratified randomized, single blind, paralleled, positive controlled, non-inferiority clinical trial. The safety and efficacy of vascular recanalization in AIS patients who are treated with either a new thrombectomy device-Skyflow or with Solitaire FR and within 8 h of symptom onset will be compared. A total of 192 patients will be enrolled, each group with 96 patients. The primary endpoint is successful recanalization rate after the operation. The secondary efficacy endpoints are the time from artery puncture to successful recanalization (mTICI 2b-3), NIHSS scores of 24 h (18–36 h), and 7 ± 2 days after the operation, mRS scores, and the rate of patients with mRS 0–2 scores 90 ± 14 days after the operation, and the success rate of instrument operation. The safety endpoints are the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage at 24 h (18–36 h) post-operation, incidence of adverse events (AE) and serious adverse events (SAE), all-cause mortality, and incidence of device defects.Discussion: This trial will provide information on the safety and efficacy of Sky-flow stent retriever in the treatment of AIS patients with anterior circulation LVO. The success of this trial will be the basis for the product to be finally officially listed and applied in China.Trial registration: Registered on 11 March 2018 with Chinese clinical trial registry. Registration number is ChiCTR1800015166.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Thrombectomy for Acute Ischemic Stroke With a New Device-Skyflow: Study Protocol for a Prospective, Multicenter, Stratified Randomized, Single-Blinded, Parallel, Positive Controlled, Non-inferiority Clinical Trial

Liu

Zhu

et al. 2021

Front. Neurol.

View full text Add to dashboard Cite

show abstract

“…The mechanical design of the Skyflow and Solitaire FR devices is similar to a certain extent. Compared with the other stent retrievers,11–13 the Skyflow has exhibited the following advantages. (1) The device was designed with a dual helical structure, excellent flexibility and adhesiveness, and a high rate of thrombus removal, avoiding excessive stimulation of the intracranial vessels.…”

Section: Discussionmentioning

confidence: 99%

Comparing the efficacy and safety of the Skyflow device with those of the Solitaire FR stent in patients with acute ischemic stroke: a prospective, multicenter, randomized, non-inferiority clinical trial

Zhou

Zhu

et al. 2021

J NeuroIntervent Surg

View full text Add to dashboard Cite

BackgroundMechanical thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in the anterior circulation. This trial aimed to indicate whether Skyflow, a new thrombectomy device, could achieve the same safety and efficacy as Solitaire FR in the treatment of AIS.MethodsThis study was a prospective, multicenter, randomized, single blind, parallel, positive controlled, non-inferiority clinical trial. Patients with intracranial anterior circulation LVO within 8 hours from onset were included to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. The primary endpoint was the rate of successful reperfusion (modified Treatment In Cerebral Infarction (mTICI) ≥2b) after the operation. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage (SAH) at 24 hours after operation.ResultsA total of 95 and 97 patients were involved in the Skyflow group and Solitaire FR group, respectively. A successful reperfusion (mTICI ≥2b) was finally achieved in 84 (88.4%) patients in the Skyflow group and 80 (82.5%) patients in the Solitaire FR group. Skyflow was non-inferior to Solitaire FR in regard to the primary outcome, with the criterion of a non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined center effect and the National Institutes of Health Stroke Scale (NIHSS) score. The rate of periprocedural sICH and SAH did not differ significantly between the two groups.ConclusionEndovascular thrombectomy with the Skyflow stent retriever was non-inferior to Solitaire FR with regard to successful reperfusion in AIS due to LVO (with a pre-specified non-inferiority margin of 12.5%).

show abstract

“…The REDIRECT trial [ 21 ] randomized 136 patients with AIS due to LVO within eight hours of symptom onset to evaluate the efficacy of the RECO flow restoration (FR) device (Genesis MedTech, Singapore) compared to the Solitaire stent-retriever. There were similar rates of 90-day functional independence (mRS 0-2), 90-day all-cause mortality, and procedure duration between the two groups [ 21 ].…”

Section: Reviewmentioning

confidence: 99%

Randomized Clinical Trials in Cerebrovascular Neurosurgery From 2018 to 2022

Kappel,

Nguyen,

Frerichs

et al. 2024

Cureus

View full text Add to dashboard Cite

There has been an exponential increase in randomized controlled trials (RCTs) on cerebrovascular disease within neurosurgery. The goal of this study was to review, outline the scope, and summarize all phase 2b and phase 3 RCTs impacting cerebrovascular neurosurgery practice since 2018. We searched PubMed, MEDLINE, Embase, ClinicalTrials.gov , and the Cochrane Central Register of Controlled Trials (CENTRAL) databases for relevant RCTs published between January 1, 2018, and July 1, 2022. We searched for studies related to eight major cerebrovascular disorders relevant to neurosurgery, including acute ischemic stroke, cerebral aneurysms and subarachnoid hemorrhage, intracerebral hemorrhage, subdural hematomas, cerebral venous thrombosis, arteriovenous malformations, Moyamoya disease and extracranial-intracranial bypass, and carotid and intracranial atherosclerosis. We limited our search to phase 2b or 3 RCTs related to cerebrovascular disorders published during the study period. The titles and abstracts of all relevant studies meeting our search criteria were included. Pediatric studies, stroke studies related to rehabilitation or cardiovascular disease, study protocols without published results, prospective cohort studies, registry studies, cluster randomized trials, and nonrandomized pivotal trials were excluded. From an initial total of 2,797 records retrieved from the database searches, 1,641 records were screened after duplicates and studies outside of our time period were removed. After screening, 511 available reports within our time period of interest were assessed for eligibility. Pediatric studies, stroke studies related to rehabilitation or cardiovascular disease, study protocols without published results, prospective cohort studies, registry studies, cluster randomized trials, and nonrandomized pivotal trials were excluded. We found 80 unique phase 2b or 3 RCTs that fit our criteria, with 165 topic-relevant articles published within the study period. Numerous RCTs in cerebrovascular neurosurgery have been published since 2018. Ischemic stroke, including mechanical thrombectomy and thrombolysis, accounted for a majority of publications, but there were large trials in intracerebral hemorrhage, subdural hemorrhage, aneurysms, subarachnoid hemorrhage, and cerebral venous thrombosis, among others. This review helps define the scope of the large RCTs published in the last four years to guide future research and clinical care.

show abstract

RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial

Cited by 7 publications

References 25 publications

Thrombectomy for Acute Ischemic Stroke With a New Device-Skyflow: Study Protocol for a Prospective, Multicenter, Stratified Randomized, Single-Blinded, Parallel, Positive Controlled, Non-inferiority Clinical Trial

Thrombectomy for Acute Ischemic Stroke With a New Device-Skyflow: Study Protocol for a Prospective, Multicenter, Stratified Randomized, Single-Blinded, Parallel, Positive Controlled, Non-inferiority Clinical Trial

Comparing the efficacy and safety of the Skyflow device with those of the Solitaire FR stent in patients with acute ischemic stroke: a prospective, multicenter, randomized, non-inferiority clinical trial

Randomized Clinical Trials in Cerebrovascular Neurosurgery From 2018 to 2022

Contact Info

Product

Resources

About