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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hungary
Semmelweis University Hospital
NOT_YET_RECRUITING
Budapest
Spain
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Contact Information
Primary
Hendrik Lambert, PhD
h.lambert@anaconda.bio
+34 933 900 508
Backup
Tina Cordaro, MPA, RN, BSN
t.cordaro@anaconda.bio
+15852040604
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 50
Treatments
Experimental: CONDA Device
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.
Related Therapeutic Areas
Sponsors
Leads: Anaconda Biomed S.L.

This content was sourced from clinicaltrials.gov