Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAnaconda Biomed S.L.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Mechanical Thrombectomy using the CONDA Stent Retriever
DeviceIntravenous 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: CONDA DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Day 0 Index Procedure2
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).
Time frame
24 hours (-8/+12) of the index procedureSponsors and contacts
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Source ClinicalTrials.gov