Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke

NCT07174505 | Recruiting DMC

• 1 other identifier: CON2501
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Acute Ischemic Stroke; Large Vessel Occlusion

Keywords

Acute Ischemic Stroke (AIS); mechanical thrombectomy; stent retriever

Outcome Measures

Primary Outcomes (2)

• Rate of device success

  The rate of device success is defined as the ability of the CONDA retriever to reach the target occluded vessel, be deployed and retrieved successfully, while facilitating reperfusion. Success will be determined if both of the following criteria are met: a) Device Performance, b) Clinical Performance

  Day 0 Index Procedure

• Incidence of symptomatic intracranial hemorrhage

  (sICH) defined per SITS-MOST criteria, attributable to the device or procedure, occurring within 24 hours (-8/+12) of the index procedure and assessed by the Imaging Core Lab and Data Monitoring Committee (DMC).

  24 hours (-8/+12) of the index procedure

Study Arms (1)

CONDA Device

EXPERIMENTAL

The CONDA device is a stent retriever intended to enable the entrapment and removal of clotted blood in the neurovasculature in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset. All participants in the study will receive Mechanical Thrombectomy using the device following standard of care practice for neurovascular procedures.

Device: Mechanical Thrombectomy using the CONDA Stent Retriever

Interventions

Mechanical Thrombectomy using the CONDA Stent Retriever DEVICE

Intravenous sedation, local or general anesthesia, and anticoagulation management will be administered following the institution's standard of care to ensure subject safety and comfort. These procedures should be applied to the target population at the discretion of the investigator and in accordance with clinical guidelines. The use of CONDA is no different than that established for other CE marked stent retrievers. The use of supportive devices including, long sheaths, guide catheters with our without balloons, distal access catheters, ANA funnel catheter, microcatheters and microwires, along with the CONDA device, will be guided by operator preference and/or center established practices. Operators are required to use these devices according to their labeling and instructions for use.

CONDA Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85 years.
• Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative).
• New focal disabling neurologic deficit consistent with acute cerebral ischemia.
• Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points.
• Pre-ictal mRS score of 0, 1 or 2.
• Treatable within 24 hours of stroke symptom onset.
• 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.
• Extended Thrombolysis in Cerebral Infarction (eTICI) Score 0 - 1, confirmed by angiography or CTA/MRA of the:
• Intracranial internal carotid artery (ICA)
• Middle cerebral artery - M1 segment
• Middle cerebral artery - M2 proximal or dominant segments
• 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.

You may not qualify if:

• Rapid neurological improvement prior to enrollment suggesting resolution of stroke.
• Subject was diagnosed with a stroke in the last 6 months.
• Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Clinical presentation suggests subarachnoid hemorrhage.
• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with antivitamin K, with INR \>3.0.
• Known baseline glucose of \<50 mg/dL or \>400 mg/dL.
• Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
• Serious, advanced, or terminal disease with anticipated life expectancy of less than 1 year.
• Known history of severe sensitivity (more than rash) to contrast medium.
• Known history of severe sensitivity to nickel, titanium metals or their alloys.
• Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) \<30 mL/min.
• Subject requires hemodialysis or peritoneal dialysis.
• Subject is a current user or has a recent history of cocaine and/or heroin use.
• Known pregnancy and/or lactating female.
• Subject is participating in a concurrent study involving an investigational drug or device that would impact the primary endpoint of this study.

Sponsors & Collaborators

• Anaconda Biomed S.L.: lead

Study Sites (2)

Semmelweis University Hospital

Budapest, 1145, Hungary

NOT YET RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hendrik Lambert, PhD

CONTACT

+34 933 900 508; h.lambert@anaconda.bio

Tina Cordaro, MPA, RN, BSN

CONTACT

+15852040604; t.cordaro@anaconda.bio

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Independent imaging core will evaluate reperfusion outcomes
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

ES (1); HU (1)