Actively Recruiting
Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
Led by Anaconda Biomed S.L. · Updated on 2025-12-11
327
Participants Needed
22
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 to 85 years
- Informed consent obtained from the subject or an acceptable surrogate
- New focal disabling neurologic deficit consistent with acute cerebral ischemia
- Baseline NIH Stroke Scale score between 6 and 25 points before procedure
- Pre-stroke modified Rankin Scale score of 0, 1, or 2
- Treatable within 16 hours of symptom onset, defined by last known symptom-free time and arterial puncture time
- If indicated, thrombolytic therapy started per institutional guidelines without delay
- Occlusion of terminal carotid artery, middle cerebral artery M1 segment, or dominant/proximal M2 segment confirmed by angiography or CTA/MRA
- Imaging showing diffusion restriction volume 50 mL on perfusion CT/MR or Alberta Stroke Program Early CT Score (ASPECTS) of 6 to 10 on baseline CT or DWI-MRI (ASPECTS 5 allowed at MRI-scoring centers)
- Indication for neurovascular thrombectomy using an approved stent retriever per instructions for use
You will not qualify if you...
- Stroke diagnosis within the past year
- Symptoms suggesting bilateral stroke or multiple stroke territories
- Known bleeding disorders, coagulation factor deficiency, anticoagulant therapy with INR >3.0, or low platelet count (<50,000/mL)
- Blood glucose below 50 mg/dL or above 400 mg/dL
- Severe uncontrolled hypertension (systolic >185 mmHg or diastolic >110 mmHg)
- Advanced or terminal illness with life expectancy under 1 year
- Cancer with metastases
- History of life-threatening allergy to contrast medium
- Renal insufficiency with creatinine 3 mg/dL or glomerular filtration rate <30 mL/min
- Current or recent cocaine and/or heroin use
- Known pregnancy or lactation
- Participation in another investigational study affecting this study's primary endpoint
- Unlikely availability for 90-day follow-up (e.g., no fixed home address, visitor from overseas)
- Evidence of intracranial hemorrhage on CT or MRI (microbleeds allowed)
- Significant brain swelling with midline shift
- Intracranial tumor except asymptomatic meningioma 2 cm
- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
- Preexisting stent near occlusion site preventing safe stent retriever use
- Vessel tortuosity preventing safe endovascular access to intracranial internal carotid artery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Baptist Health Medical Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
2
Grady Memorial Hospital, Emory
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Advocate Health
Park Ridge, Illinois, United States, 60068
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
6
University of Buffalo Neurosurgery
Buffalo, New York, United States, 14203
Actively Recruiting
7
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
8
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
9
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
10
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
11
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
12
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
Actively Recruiting
13
Fondation Rothschild
Paris, France, 75019
Actively Recruiting
14
Hospital Foch
Suresnes, France, 92150
Actively Recruiting
15
Centre Hospitalier Universitaire de Toulouse
Toulouse, France, 40031
Actively Recruiting
16
Semmelweis University Hospital
Budapest, Hungary, 1145
Actively Recruiting
17
Hospital Universitario Vall D'Hebron
Barcelona, Spain, 08035
Actively Recruiting
18
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
19
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
20
Hospital Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
21
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
22
Aydin University Hospital
Istanbul, Turkey (Türkiye), 34295
Actively Recruiting
Research Team
H
Hendrik Lambert
CONTACT
T
Tina Cordaro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here