Favorable first-pass recanalization rates with NeVa™ thrombectomy device in acute stroke patients: Initial clinical experience

Akpınar, Çetin Kürşad; Özdemi̇r, Atilla Özcan; Gürkaş, Erdem; Bilgiç, Adnan; Aykaç, Özlem; İnanç, Yusuf; Gıray, Semih

doi:10.1177/1591019920938223

Cited by 17 publications

(13 citation statements)

References 41 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Besides being used clinically, FPE mTICI ≥2B is increasingly being used to evaluate thrombectomy devices as a new benchmark. This is because in the latest trials, devices achieve >90% reperfusion rates, and there is very little differentiating them (16)(17)(18). A new threshold, FPE mTICI ≥2B or even FPE mTICI 2c-3, with its marked clinical improvement, is a potential way to evaluate these devices and tease apart their small differences, as we strive to achieve perfect stroke outcomes.…”

Section: First-pass Recanalization: a New Target For Thrombectomymentioning

confidence: 99%

“…Successful reperfusion was achieved at similar rates with direct aspiration (85.4%) and stent retrievers (83.1%), p = 0.53. Nonetheless, this was a failed superiority trial that was underpowered to demonstrate a significant difference between the two techniques (17).…”

Section: Techniques Direct Aspiration Vs Stent Retriever: Aster and Compass Trialmentioning

confidence: 99%

“…As there were certain challenges with compatibility of BCGs and large-bore distal aspiration catheters, the industry is keen on designing novel aspiration catheters that are compatible with their BCGs (e.g., novel 7Fr Catalyst fits into 8Fr Flowgate or Flowgate2 BGC). The ASTER trial documented a trend toward better mTICI 3 and better clinical outcomes in BGC-treated patients using direct aspiration (17). In the PROTECT trial with 200 patients, the group using both direct aspiration and a BGC had shorter procedure times (29 vs. 40 min; p = 0.002), higher rate of successful recanalization (100 vs. 78%; p = 0.001) and a higher rate of complete reperfusions (70 vs. 39%; p < 0.001) compared with sole distal aspiration during MT (22).…”

Section: Devices Balloon Guide Cathetermentioning

confidence: 99%

“…It is compatible with 0.021 in. microcatheters and is available in multiple sizes: M1-S (4 × 22 mm), M1 (4 × 30 mm), and T (4.5 × 37 mm) with the M1-S having no proximal “flow restoration zone” ( 53 ). The final segment is fashioned into a closed-ended basket, which retains the thrombus that has fallen into the Drop Zone openings.…”

Section: Devicesmentioning

confidence: 99%

See 3 more Smart Citations

Evidence-Based Updates to Thrombectomy: Targets, New Techniques, and Devices

et al. 2021

View full text Add to dashboard Cite

Endovascular thrombectomy (EVT) has been validated in several randomized controlled trials in recent years for its efficacy in the treatment of acute ischemic strokes (AIS) and is now the standard of care according to international guidelines. However, in about 20% of EVT procedures, recanalization is not achieved, and over 50% of patients who undergo EVT still do not have good functional outcome. In this article, we provide an extensive review of the latest evidence and developments in the field of EVT, with particular focus on the factors that improve patient outcomes. These factors include new and adjunctive techniques such as combination of direct aspiration and stent retriever, intra-arterial urokinase or 2b/3a inhibitors, rescue stenting, as well as novel devices including balloon guide catheters and the newer generations of aspiration catheters and stent retrievers. We also examined the latest notion of using first-pass effect (FPE) as the target to achieve during EVT, which has been associated with an improved functional outcome. While the field of EVT has been rapidly evolving, further research is required in specific AIS patient populations such as those with large ischemic core, late presentation beyond 24 h, posterior circulation strokes, and with distal medium vessel occlusion or tandem lesions to better assess its efficacy and safety.

show abstract

Section: First-pass Recanalization: a New Target For Thrombectomymentioning

confidence: 99%

Section: Techniques Direct Aspiration Vs Stent Retriever: Aster and Compass Trialmentioning

confidence: 99%

Section: Devices Balloon Guide Cathetermentioning

confidence: 99%

Section: Devicesmentioning

confidence: 99%

See 2 more Smart Citations

Evidence-Based Updates to Thrombectomy: Targets, New Techniques, and Devices

et al. 2021

View full text Add to dashboard Cite

show abstract

“…At present, the China Food and Drug Administration (CFDA) has approved several thrombectomy devices of foreign companies to be listed domestically, including Solitaire FR (Medtronic/ev3), Trevo thrombectomy system (Stryker), and Revive self-expanding intracranial thrombectomy device (Codman). 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).…”

Section: Introductionmentioning

confidence: 99%

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

Treatment of Acute Ischemic Stroke

Harrigan,

Deveikis

2023

Contemporary Medical Imaging

View full text Add to dashboard Cite

Favorable first-pass recanalization rates with NeVa™ thrombectomy device in acute stroke patients: Initial clinical experience

Cited by 17 publications

References 41 publications

Evidence-Based Updates to Thrombectomy: Targets, New Techniques, and Devices

Evidence-Based Updates to Thrombectomy: Targets, New Techniques, and Devices

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

Treatment of Acute Ischemic Stroke

Contact Info

Product

Resources

About