Status:
COMPLETED
Complete Occlusion of Coilable Aneurysms
Lead Sponsor:
Chestnut Medical Technologies
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
21-75 years
Phase:
PHASE3
Brief Summary
To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms
Eligibility Criteria
Inclusion
- Age 21 to 75 years, inclusive
- Patient has a single target IA that:
- is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
- is saccular
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00777907
Start Date
October 1 2008
End Date
April 1 2015
Last Update
August 7 2015
Active Locations (2)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
SUNY Stony Brook
Stony Brook, New York, United States, 11794