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New treatment option for Acute Ischemic Stroke
Official title Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT07174505
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can 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.
- If indicated, thrombolytic therapy shall be initiated following recommendations established by the AHA/ASA and/or ESO Guidelines. people 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.
What rules you out
- 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.
- Known baseline glucose of \ 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Budapest, Hungary
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Budapest, Hungary; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.