| 1. |
|
|
| 2. |
- Fernandez-Sanchez, D, et al.
(författare)
-
Suction force rather than aspiration flow correlates with recanalization in hard clots: an in vitro study model
- 2021
-
Ingår i: Journal of neurointerventional surgery. - : BMJ. - 1759-8486 .- 1759-8478. ; 13:12, s. 1157-1161
-
Tidskriftsartikel (refereegranskat)abstract
- ANA Advanced Neurovascular Access provides a novel funnel component designed to reduce clot fragmentation and facilitate retrieval in combination with stent-retrievers (SRs) in stroke patients by restricting flow and limiting clot shaving. In previous publications ANA presented excellent in vitro/in vivo efficacy data, especially with fibrin-rich hard clots. We aimed to determine the main physical property responsible for these results, namely suction force versus aspiration flow.MethodsWe evaluated in a bench model the suction force and flow generated by ANA and compared them to other neurovascular catheters combined with a SR (Solitaire). Aspiration flow was evaluated with a flow rate sensor while applying vacuum pressure with a pump. Suction force was determined using a tensile strength testing machine and a purposely designed tool that completely seals the device tip simulating complete occlusion by a hard clot. Suction force was defined as the force needed to separate the device from the clot under aspiration. All experiments were repeated five times, and mean values used for comparisons.ResultsAspiration flow increased with the inner diameter of the device: ANA 1.85±0.04 mL/s, ACE68 3.74±0.05 mL/s, and 8F-Flowgate2 5.96±0.30 mL/s (P<0.001). After introducing the SR, the flow was reduced by an average of 0.57±0.12 mL/s. Due to its larger distal surface, ANA suction force (1.69±0.40 N) was significantly higher than ACE68 (0.26±0.04 N) and 8F-Flowgate2 (0.42±0.06 N) (P<0.001). After introducing the SR, suction force variation was not relevant except for ANA that increased to 2.64±0.41 N.ConclusionDespite lower in vitro aspiration flow, the ANA design showed a substantially higher suction force than other thrombectomy devices.
|
|
| 3. |
|
|
| 4. |
|
|
| 5. |
- Siddiqui, AH, et al.
(författare)
-
Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods
- 2022
-
Ingår i: Journal of neurointerventional surgery. - : BMJ. - 1759-8486 .- 1759-8478. ; 14:8, s. 783-787
-
Tidskriftsartikel (refereegranskat)abstract
- Relationships between occlusive clot histopathology, baseline characteristics, imaging findings, revascularization rates, and clinical outcomes of stroke patients with large vessel occlusion (LVO) are not well understood. This study will assess the real-world experience on the efficacy and safety of using the EmboTrap device as the first approach in LVO patients and explore the associations between clot histological characteristics, imaging and clinical findings, revascularization rates, and clinical outcomes.MethodsProspective, global, multicenter, single-arm, imaging core laboratory, and clot analysis central laboratory observational registry. Adult patients (>18 years) with LVO, treated with EmboTrap as the first attempted device, will be eligible for study participation.ResultsUp to 1000 subjects at 50 international sites may be enrolled. Occlusive clots will be collected from at least 500 subjects. Independent central and imaging core laboratories will perform clot analysis and image adjudication. Statistical analysis will assess the association between imaging and clinical findings, clot characteristics, subject comorbidities, revascularization, and clinical outcomes. Study endpoints are functional independence (modified Rankin Scale score ≤2 at 90 days), expanded Thrombolysis In Cerebral Infarction (eTICI) score ≥2b50 rate, first-pass effect, number of passes, embolization into new territory, symptomatic intracranial hemorrhage, and 90-day mortality.ConclusionsThe EXCELLENT registry will provide reproducible effectiveness and safety data of EmboTrap for its use for mechanical thrombectomy. Additionally, the study will characterize the blood clots retrieved during mechanical thrombectomy with respect to their composition and histopathological analysis and potential correlations with clinical and imaging findings.Trial registration numberNCT03685578.
|
|
| 6. |
|
|
