N/A
N=34
Contour Neurovascular System - European Pre-Market Unruptured Aneurysm
Intracranial Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT03680742 ↗Enrolled (actual)
34
Serious AEs
38.2%
Results posted
May 2021
Primary outcome: Primary: Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment. — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contour Neurovascular System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cerus Endovascular, Inc.
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment. |
1 | — |
| PRIMARY Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months. |
14; 9; 6 | — |
Summary
Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour").
The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.
Eligibility Criteria
Patients of all genders who meet all indications and contraindications will proceed to implantation.
Inclusion criteria
- Patient's indication for treatment of unruptured aneurysm is according to the national/international guidelines.
- Age 18-80 years at screening
- Patients who are suitable for non-emergency endovascular embolization of saccular IAs
- IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU
- Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements
- Patient able to able to give their informed consent can be included in this study. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study.
Exclusion criteria
The presence of condition that may create unacceptable risk during the aneurysm embolization procedure, such as patients with:
- Ruptured aneurysm
- Patient anatomy or physiology considered unsuitable for endovascular treatment
- Contraindication for arterial access
- Largest measured IA equatorial diameter >8.5 mm or 8 mm or 50%
- Anticoagulation medications such as warfarin that cannot be discontinued
- Pregnant, breastfeeding or planning pregnancy in the next 2 years
- Acute / chronic renal failure (including dialysis); Creatinine > 2.00 mg/dl or > 182 μmol/L
- Myocardial Infarction, Stroke or TIA within the last 6 months
- Any other medical issue within the brain that precludes the device implantation such as brain surgery, radiation in the target area of intervention, acute traumatic craniocerebral injury, etc.
- Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures or death within 2 years (e.g., liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.)
- Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes
Data sourced from ClinicalTrials.gov (NCT03680742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.