CONDA stent retriever for reopening large-vessel blockages in acute ischemic stroke.

A Prospective, Single-Arm, Multi-Center Study to Assess the Safety, Performance, and Preliminary Efficacy of Mechanical Thrombectomy Using the CONDA Stent Retriever in Subjects With Acute Ischemic Stroke

The CONDA stent retriever will be tried to reopen blocked large brain arteries in adults with acute ischemic stroke treated within 24 hours of symptom onset.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Anaconda Biomed S.L. (Industry-sponsored)
• Locations: 2 sites (Budapest and 1 other locations)
• Trial ID: NCT07174505 on ClinicalTrials.gov

What this trial studies

ARTEMIS is a pilot, prospective, multi-center, single-arm, open-label interventional study that uses standard clinical and imaging assessments to enroll adults with acute ischemic stroke due to large vessel occlusion treated within 24 hours. The CONDA stent retriever is used for mechanical thrombectomy and operators may use supportive catheters and devices per local practice and labeling. The primary performance outcome is device success (reach, deploy, retrieve and facilitate reperfusion) and the primary safety outcome is symptomatic intracranial hemorrhage within 24 hours. Key eligibility includes age 18–85, baseline NIHSS 6–25, pre-stroke mRS 0–2, treatable LVO in specified intracranial vessels, and ASPECTS 6–10 on baseline imaging.

Who should consider this trial

Good fit: Adults 18–85 with acute ischemic stroke from a treatable large vessel occlusion within 24 hours of symptom onset, baseline NIHSS 6–25, pre-stroke mRS 0–2, and ASPECTS 6–10 are the ideal candidates.

Not a fit: Patients outside the 24-hour window, with extensive early infarction (ASPECTS <6), non-large-vessel occlusions, severe pre-stroke disability, or medical contraindications to thrombectomy are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the CONDA device could improve the chance of timely reperfusion with a safety profile comparable to existing stent retrievers.

How similar studies have performed: Other CE-marked stent retrievers using the same mechanical thrombectomy approach have demonstrated improved reperfusion and clinical outcomes, so this device follows an established and successful technique.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 85 years.
2. Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative).
3. New focal disabling neurologic deficit consistent with acute cerebral ischemia.
4. Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points.
5. Pre-ictal mRS score of 0, 1 or 2.
6. Treatable within 24 hours of stroke symptom onset.
7. If indicated, thrombolytic therapy shall be initiated following recommendations established by the AHA/ASA and/or ESO Guidelines. Subjects eligible for IV thrombolysis should receive it without delay.
8. Extended Thrombolysis in Cerebral Infarction (eTICI) Score 0 - 1, confirmed by angiography or CTA/MRA of the:

   1. Intracranial internal carotid artery (ICA)
   2. Middle cerebral artery - M1 segment
   3. Middle cerebral artery - M2 proximal or dominant segments
9. Imaging criteria:

   * Alberta Stroke Program Early CT Score (ASPECTS) 6 to 10 on baseline CT or DWI-MRI.
   * If automated assessment, core volume of ≤50 cc on CTP/ DWI-MRI.

Exclusion Criteria:

The following exclusion criteria will be assessed pre-operatively:

1. Rapid neurological improvement prior to enrollment suggesting resolution of stroke.
2. Subject was diagnosed with a stroke in the last 6 months.
3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
4. Clinical presentation suggests subarachnoid hemorrhage.
5. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with antivitamin K, with INR \>3.0.
6. Known baseline glucose of \<50 mg/dL or \>400 mg/dL.
7. Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
8. Serious, advanced, or terminal disease with anticipated life expectancy of less than 1 year.
9. Known history of severe sensitivity (more than rash) to contrast medium.
10. Known history of severe sensitivity to nickel, titanium metals or their alloys.
11. Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) \<30 mL/min.
12. Subject requires hemodialysis or peritoneal dialysis.
13. Subject is a current user or has a recent history of cocaine and/or heroin use.
14. Known pregnancy and/or lactating female.
15. Subject is participating in a concurrent study involving an investigational drug or device that would impact the primary endpoint of this study.
16. Subject is unlikely to be available for a 90-day follow-up (e.g., no fixed home address, visitor from overseas, etc.)
17. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
18. CT or MRI evidence of significant mass effect with midline shift.
19. CT or MRI evidence of intracranial tumor (except asymptomatic meningioma of ≤ 2cm in diameter).
20. CT or MR evidence of cerebral vasculitis.
21. Suspicion of aortic dissection, presumed septic embolus, or bacterial endocarditis.
22. History of preexisting stent proximal to or at the occlusion site that may preclude safe deployment or recovery of the stent retriever.

    The following exclusion criteria will be assessed intra-operatively:
23. eTICI score improvement to greater than eTICI 1 after initial screening and prior to intervention.
24. Initially treated with a different thrombectomy device during the current study procedure.
25. Vessel tortuosity too difficult to allow endovascular access of the intracranial internal carotid artery (ICA) per investigator judgement. Indicators of vessel tortuosity include but are not limited to the presence of carotid loops and type 3 aortic arches.
26. Evidence of tandem lesions, including complete occlusion, high-grade stenosis or arterial dissection in the extracranial or intracranial internal carotid artery (ICA), requiring treatment or preventing access to thrombus.
27. Underlying intracranial atherosclerotic disease (ICAD) lesions responsible for the target occlusion.
28. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
29. Inability to gain arterial access.

Where this trial is running

Budapest and 1 other locations

• Semmelweis University Hospital — Budapest, Hungary (Not_yet_recruiting)
• Vall d'Hebron University Hospital — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Hendrik Lambert, PhD

Conditions Acute Ischemic Stroke; Large Vessel Occlusion; mechanical thrombectomy; stent retriever