Actively Recruiting
Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke
Led by Anaconda Biomed S.L. · Updated on 2025-09-16
50
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate the safety and performance of the CONDA stent retriever in patients with acute ischemic stroke due to large vessel occlusion, treated within 24 hours of symptom onset. The main objectives are: * To determine the rate of device success, defined as the ability of the CONDA retriever to reach the blocked vessel, be deployed and retrieved successfully, and facilitate reperfusion. * To evaluate safety, measured as the rate of symptomatic intracranial hemorrhage within 24 hours of the procedure. The use of CONDA in this study follows the same approach as other CE-marked stent retrievers. Supportive devices (such as long sheaths, guide catheters, balloon catheters, distal access catheters, the ANA funnel catheter, microcatheters, and microwires) may be used according to investigator preference and local practice, in line with their labeling and instructions for use. Participants will: * Be evaluated using standard clinical and imaging assessments to confirm eligibility. * Undergo mechanical thrombectomy with the CONDA device, with or without supportive devices as selected by the treating physician. * Have standard follow-up evaluations to assess treatment safety and effectiveness.
CONDITIONS
Official Title
Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- Informed consent obtained from patient or legal representative
- New focal disabling neurologic deficit consistent with acute cerebral ischemia
- Baseline NIH Stroke Scale score between 6 and 25 points prior to procedure
- Pre-stroke modified Rankin Scale score of 0, 1, or 2
- Treatable within 24 hours of stroke symptom onset
- If indicated, thrombolytic therapy started as recommended by stroke guidelines
- Imaging confirmation of large vessel occlusion in intracranial internal carotid artery or middle cerebral artery (M1 or proximal M2 segments)
- Alberta Stroke Program Early CT Score (ASPECTS) between 6 and 10 on baseline CT or DWI-MRI
- Core volume of 50 cc or less on automated assessment if applicable
You will not qualify if you...
- Rapid neurological improvement before enrollment
- Stroke diagnosis within the last 6 months
- Symptoms suggesting bilateral stroke or stroke in multiple areas
- Signs of subarachnoid hemorrhage
- Known bleeding disorders or high blood thinning levels (INR >3.0)
- Blood glucose below 50 mg/dL or above 400 mg/dL
- Severe uncontrolled high blood pressure (systolic >185 mmHg or diastolic >110 mmHg)
- Serious advanced disease with life expectancy less than 1 year
- Severe allergy to contrast medium or metals like nickel or titanium
- Kidney problems with creatinine ≥3 mg/dL or GFR less than 30 mL/min
- Need for hemodialysis or peritoneal dialysis
- Current or recent cocaine or heroin use
- Pregnancy or breastfeeding
- Participation in another study affecting this study's outcomes
- Unlikely to be available for 90-day follow-up
- Brain hemorrhage on CT or MRI (microbleeds allowed)
- Significant brain swelling with midline shift
- Brain tumor except small asymptomatic meningioma
- Cerebral vasculitis
- Suspected aortic dissection, septic embolus, or bacterial endocarditis
- Preexisting stent near occlusion site preventing safe device use
- Improvement in vessel opening score before intervention
- Use of different thrombectomy device during this procedure
- Vessel anatomy preventing safe endovascular access
- Tandem lesions blocking access or needing treatment
- Intracranial atherosclerotic disease causing the blockage
- Blockages in multiple vascular territories
- Inability to gain arterial access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Semmelweis University Hospital
Budapest, Hungary, 1145
Not Yet Recruiting
2
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Actively Recruiting
Research Team
H
Hendrik Lambert, PhD
CONTACT
T
Tina Cordaro, MPA, RN, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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