Active — Not RecruitingNot Applicable

French eCLIPs™ Efficacy and Safety Investigation

France119 participantsStarted 2021-12-16

Plain-language summary

The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient whose age is greater than 18 years old
✓. Patient with an unruptured or previously ruptured (at least 1 month from date of rupture and with partial occlusion of the dome of the aneurysm by endovascular techniques or by open neurosurgery, and in stable neurological condition-WFNS I and II with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation of Basilar Tip or Carotid Terminus with a minimal diameter of 5mm and a maximal diameter \<25mm, has a neck length of \>4mm or dome:neck ratio \<2, branch artery diameters in the range of 2.0mm to 3.25mm
✓. Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 2.0mm and 3.25mm
✓. Patient understands the nature of the procedure and has the capacity to provide informed consent (including fluency in French language)
✓. Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up evaluations as per standard clinical practice

✕. Patient with an aneurysm deemed to be an eligible candidate for surgical clipping by the investigator
✕. Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region
✕. Major surgery within previous 30 days or planned in the next 120 days after enrolment
✕. Patient with an International Normalized Ratio (INR) ≥ 1.5
✕. Patient with serum creatinine level ≥104 µmol/L (or 2.5mg/dL) at time of enrolment
✕. Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
✕. Patient who has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation
✕. Patient with any condition that, in the opinion of the treating physician, would place the participant at a high risk of embolic stroke or with any medical co-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolled diabetes, blood disorders)

Complete aneurysm occlusion with no recurrence or re-treatment

Timeframe: 12 months

Major stroke or non-accidental death within 30 days, or major ipsilateral stroke or neurological death between 31 days and 12 months

Timeframe: 12 months

NCT IDNCT05330897

SponsorEvasc Medical Systems Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-16

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient whose age is greater than 18 years old
✓. Patient with an unruptured or previously ruptured (at least 1 month from date of rupture and with partial occlusion of the dome of the aneurysm by endovascular techniques or by open neurosurgery, and in stable neurological condition-WFNS I and II with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation of Basilar Tip or Carotid Terminus with a minimal diameter of 5mm and a maximal diameter \<25mm, has a neck length of \>4mm or dome:neck ratio \<2, branch artery diameters in the range of 2.0mm to 3.25mm
✓. Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 2.0mm and 3.25mm
✓. Patient understands the nature of the procedure and has the capacity to provide informed consent (including fluency in French language)
✓. Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up evaluations as per standard clinical practice

✕. Patient with an aneurysm deemed to be an eligible candidate for surgical clipping by the investigator
✕. Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region
✕. Major surgery within previous 30 days or planned in the next 120 days after enrolment
✕. Patient with an International Normalized Ratio (INR) ≥ 1.5
✕. Patient with serum creatinine level ≥104 µmol/L (or 2.5mg/dL) at time of enrolment
✕. Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
✕. Patient who has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation
✕. Patient with any condition that, in the opinion of the treating physician, would place the participant at a high risk of embolic stroke or with any medical co-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolled diabetes, blood disorders)