Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chestnut Medical Technologies
Age
21–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 21 to 75 years, inclusive
Patient has a single target IA that:
1. is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
2. is saccular
3. has a parent vessel with diameter 2.5-5.0 mm
If target IA has a neck \>4 mm, at least 2 of 3 members of an independent expert committee (IEC) have confirmed that coil embolization with optional adjunctive techniques\*\* has a very high likelihood of procedural success (i.e., coil placement and retention)
Subject has provided written informed consent using the IRB-approved consent form
Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
* \*\* Adjunctive techniques include intravascular balloons \["balloon remodeling"\], 3D coils, dual catheter techniques.
You may not be if
Target IA has BOTH neck \>4 mm AND size (maximum fundus diameter) \>10 mm
More than one IA requires treatment in the next 6 months
Subarachnoid hemorrhage in the past 60 days
Any intracranial hemorrhage in the last 42 days
Major surgery in the last 42 days
Coils in place in the target IA
Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
Known irreversible bleeding disorder
Platelet count \< 100 x 103 cells/mm3 or known platelet dysfunction
Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
Prior stent placement at target site
Contraindication to CT scan AND MRI
Known allergy to contrast used in angiography that cannot be medically controlled
Known severe allergy to platinum or cobalt/chromium alloys
Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL)
Woman of child-bearing potential who cannot provide a negative pregnancy test
Evidence of active infection at the time of treatment
Other known conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
Current use of cocaine or other illicit substance
Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
Extracranial stenosis greater than 50% in the carotid artery
Intracranial stenosis greater than 50% in the treated vessel
Clareo Health | Complete Occlusion of Coilable Aneurysms
