Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)
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|ClinicalTrials.gov Identifier: NCT04095767|
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : February 5, 2020
The ANA catheter system (may also be designated as "ANA system", "ANA 18 -002" or "ANA device") is a distal access catheter designed to assist in neurovascular procedures by facilitating the insertion and guiding of other devices (i.e. retrieval devices and intravascular catheters) and restricting blood flow at the target position. It is a sterile, single-use, disposable intravascular device comprised of two coaxial catheters (delivery catheter and funnel catheter) consisting of sections of variable stiffness. The funnel catheter is comprised of a radiopaque nitinol braid (self-expanding funnel), covered by a continuous silicone coating that, when deployed, provides local and temporary flow restriction. The delivery catheter has a hydrophilic coating to reduce friction during use and a radiopaque marker on the distal end. Both catheters have Luer lock hubs on their proximal end.
The proposed study has been designed to collect prospective clinical evidence to compare the Anaconda ANA device to similar devices used for guiding and supporting stent retrievers during neurothrombectomy procedures. The protocol has been designed to replicate the patient population enrolled in prior studies of similar devices. The primary endpoint will be ability of the investigational device to facilitate stentriever deployment and neurothrombectomy in the anterior circulation, with successful reperfusion defined as achieving a modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2b in the target vessel with ≤3 passes of the investigational device without the use of rescue therapy. Follow-up at 24h, Day 5 (+/- 12 h) or discharge, whichever comes first and at 90 days will allow documentation of the clinical outcome of the neurothrombectomy procedure as a whole and detect any device related and other complications, making use of the ANA device for distal access.
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Ischemic||Device: Neurothrombectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, single-arm, multi-center, study|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Single-Arm, Multi-center Study to Assess the Safety and Performance of the ANA Catheter System, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke|
|Actual Study Start Date :||September 21, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Treatment arm
The thrombectomy in eligible patients will be carried out by making use of the device under investigation.
Intra-arterial recanalization therapy or mechanical thrombectomy (MT) is a therapeutic option for patients who are not candidates for t-PA or in whom t-PA has failed. MT is performed by means of various devices (Merci Revive, Penumbra, etc.). There are currently two major approaches to MT: the so-called stent retrievers (used with or without a balloon catheter), and catheters used for direct aspiration (manual with syringe or by aspiration pump via distal access catheters [DACs]). Moreover, both techniques can be combined. MT may be performed following IV t-PA, as a stand alone therapy, or in conjunction with IA thrombolysis.
- modified Thrombolysis in Cerebral Infarction (mTICI) score [ Time Frame: At end of neurothrombectomy ]The ability of the investigational device to facilitate stentriever deployment and to perform neurothrombectomy in the anterior circulation, with successful reperfusion defined as achieving a modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2b in the target vessel with ≤3 passes of the investigational device without the use of rescue therapy.
- Occurrence of serious Adverse Device Effects [ Time Frame: Up to 90 days ]The occurrence of all serious adverse device effects up to 90-days post-procedure, including symptomatic IntraCerebral Hemorrhage (sICH) at 24h (-8/+12 h).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095767
|Contact: Lieven Huysse, MDfirstname.lastname@example.org|
|Hospital Germans Trias||Recruiting|
|Badalona, Catalunya, Spain, 08916|
|Contact: Sebastià Remollo, MD +34932746000|
|Hospital Universitario Cruces||Recruiting|
|Bilbao, Vizcaya, Spain, 48903|
|Contact: Marimar Freijo, MD +34946006000|
|Contact: Eva M González, MD +34946006000|
|Hospital Vall d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Alejandro Tomasello, MD|
|Hospital Clínic de Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Jordi Blasco, MD|
|Hospital Universitari de Bellvitge||Recruiting|
|Barcelona, Spain, 08907|
|Contact: Maria Angeles de Miquel Miquel, MD|
|Study Director:||Lieven Huysse, MD||Anaconda Biomed SL|