Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Anaconda Biomed S.L.
Study ID
NCT06370182
Status
Recruiting
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Conditions

  • Acute Ischemic Stroke From Large Vessel Occlusion

Eligibility Criteria

Sex
ALL
Age
22 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • ANA Funnel Catheter — DEVICE
    Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.
  • Control — DEVICE
    Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.

Study Details

The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy (MT) using the ANA funnel catheter in its intended use, which is to facilitate the navigation and deployment of other neurovascular devices and to allow flow arrest during mechanical thrombectomy procedures performed in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset.

Key Dates

Start date
Sep 9, 2024
Status verified
Dec 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
327 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ANA Funnel Catheter Group
    Mechanical thrombectomy using a stent retriever delivered by the ANA device.
  • Active Comparator: Control Group
    Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter.

Primary Outcome Measure

Proportion of subjects with "near-complete" reperfusion after one thrombectomy pass (FPE, eTICI 2c-3, extended Thrombolysis in Cerebral Infarction scale) in the target vessel. [ Time Frame: intra-operative ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Baptist Health Medical CenterJacksonvilleFlorida32207
(+1) 904-487-2469
Ricardo Hanel (PRINCIPAL_INVESTIGATOR)
Grady Memorial Hospital, EmoryAtlantaGeorgia30322
(404) 778-1700
Diogo Haussen (PRINCIPAL_INVESTIGATOR)
Advocate HealthPark RidgeIllinois60068
847-430-6108
Demetrius Lopes (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
319-353-6629
Edgar Samaniego (PRINCIPAL_INVESTIGATOR)
Boston Medical CenterBostonMassachusetts02118
617-638-6609
Mohamad Abdalkader (PRINCIPAL_INVESTIGATOR)
University of Buffalo NeurosurgeryBuffaloNew York14203
716-218-1000
Rosalind Lai (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
(+1)7634969283
Shahram Majidi (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
503-494-8450
Scott Rewinkel (PRINCIPAL_INVESTIGATOR)
University of Pittsburg Medical CenterPittsburghPennsylvania15213
Alhamza Al-Bayati (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
615-322-7417
Michael Froehler (PRINCIPAL_INVESTIGATOR)
Aurora St. Luke's Medical CenterMilwaukeeWisconsin53215
Sudeepta Dandapat (PRINCIPAL_INVESTIGATOR)

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By research site
Baptist Health Medical Center· Jacksonville, FLGrady Memorial Hospital, Emory· Atlanta, GAAdvocate Health· Park Ridge, ILUniversity of Iowa· Iowa City, IABoston Medical Center· Boston, MAUniversity of Buffalo Neurosurgery· Buffalo, NY

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