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

NCT06370182 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2025-12-11

No results posted yet for this study

Summary

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.

Conditions

  • Acute Ischemic Stroke From Large Vessel Occlusion

Interventions

DEVICE

ANA Funnel Catheter

Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.

DEVICE

Control

Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.

Sponsors & Collaborators

  • Anaconda Biomed S.L.

    lead INDUSTRY

Principal Investigators

  • Adnan Siddiqui, MD, PhD, FAHA · Jacobs School of Medicine & Biomedical Sciences

  • Santiago Ortega-Gutierrez, MD, MSc, FAHA, FSVIN · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • France
  • Hungary
  • Spain
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370182 on ClinicalTrials.gov