Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT07174505
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke
Sponsor:
Anaconda Biomed S.L.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTEMIS
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: