Acute Ischemic StrokeARTEMISNCT07174505
Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke
A study testing Mechanical Thrombectomy using the CONDA Stent Retriever in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Anaconda Biomed S.L. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion
- What is being tested?
- Mechanical Thrombectomy using the CONDA Stent Retriever
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- The following exclusion criteria will be assessed pre-operatively:
- 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.
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- 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.
- Subject is unlikely to be available for a 90-day follow-up (e.g., no fixed home address, visitor from overseas, etc.)
- CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
- CT or MRI evidence of significant mass effect with midline shift.
- CT or MRI evidence of intracranial tumor (except asymptomatic meningioma of ≤ 2cm in diameter).
- CT or MR evidence of cerebral vasculitis.
- Suspicion of aortic dissection, presumed septic embolus, or bacterial endocarditis.
- 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:
- eTICI score improvement to greater than eTICI 1 after initial screening and prior to intervention.
- Initially treated with a different thrombectomy device during the current study procedure.
- 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.
- 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.
- Underlying intracranial atherosclerotic disease (ICAD) lesions responsible for the target occlusion.
- Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- Inability to gain arterial access.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Hungary1 site, 1 recruiting
- Not yet recruiting
Semmelweis University Hospital
Budapest, 1145
Sandor Nardai, MD, snardai@gmail.com
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
Manuel Requena, MD, +34661656835, m.requenaruiz@gmail.com
About this study
Official title: 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 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:
Read more
- 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.
Read the detailed description
ARTEMIS is a pilot prospective, multi-center, single-arm, open-label, interventional study. Standard of care clinical and imaging stroke assessments will determine subject eligibility. The objective of this study is to assess the performance, safety and preliminary efficacy of mechanical thrombectomy (MT) using the CONDA device in its intended use as a stent retriever 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. The ARTEMIS study is designed to demonstrate that the use of CONDA does not adversely impact the safety and effectiveness of a conventional stent retriever MT procedures.
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion
- Being tested
- Mechanical Thrombectomy using the CONDA Stent Retriever
- Keywords
- Acute Ischemic Stroke (AIS), mechanical thrombectomy, stent retriever
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Thrombectomy using the CONDA Stent RetrieverDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mechanical Thrombectomy using the CONDA Stent Retriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 24 hours (-8/+12) of the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anaconda Biomed S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174505
- Sponsor's protocol ID
- CON2501
- Acronym
- ARTEMIS
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07174505
- Acronym / sponsor ID
- ARTEMIS / CON2501
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion
- Keywords
- Acute Ischemic Stroke (AIS), mechanical thrombectomy, stent retriever
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Anaconda Biomed S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ARTEMIS is a pilot prospective, multi-center, single-arm, open-label, interventional study. Standard of care clinical and imaging stroke assessments will determine subject eligibility. The objective of this study is to assess the performance, safety and preliminary efficacy of mechanical thrombectomy (MT) using the CONDA device in its intended use as a stent retriever 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. The ARTEMIS study is designed to demonstrate that the use of CONDA does not adversely impact the safety and effectiveness of a conventional stent retriever MT procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONDA Device | Experimental | Device: Mechanical Thrombectomy using the CONDA Stent RetrieverThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Thrombectomy using the CONDA Stent RetrieverIntravenous 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. | Device | CONDA Device |
Primary outcome
Rate of device success
Time frame: Day 0 Index Procedure
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
Incidence of symptomatic intracranial hemorrhage
Time frame: 24 hours (-8/+12) of the index procedure
(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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Thrombectomy using the CONDA Stent Retriever in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Anaconda Biomed S.L. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hendrik Lambert, PhD (+34 933 900 508, h.lambert@anaconda.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device success (time frame: Day 0 Index Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.