Clinical trial NCT00777907: Complete Occlusion of Coilable Aneurysms
Official title: Complete Occlusion of Coilable Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intracranial Aneurysm
Keywords: neurovascular embolization
therapeutic embolization
Lead sponsor: Chestnut Medical Technologies
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death.
timeFrame: 180 days
Secondary outcomes:
measure: Rate of complete target aneurysm occlusion
timeFrame: 1, 3 and 5 years
measure: Incidence of ipsilateral major stroke
timeFrame: 180 days
measure: Change in modified Rankin scale (MRS)
timeFrame: 180 days, 1, 3 and 5 years
measure: Incidence of device-related adverse events
timeFrame: 180 days, 1, 3 and 5 years
measure: Change from baseline in neurologic signs or symptoms related to the target aneurysm
timeFrame: 180 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
Study officials:
affiliation: Barrow Neurologic Institute
name: David Fiorella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: