Complete Occlusion of Coilable Aneurysms

Intracranial Aneurysm Clinical Trial

— COCOA  

Official title:

Complete Occlusion of Coilable Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777907
• Other study ID #: CLP-0004
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2008
• Last updated: August 5, 2015
• Start date: October 2008
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Chestnut Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Pipeline Embolization Device (PED)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.
• Coil embolization
Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.

Locations

Country	Name	City	State
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	SUNY Stony Brook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Chestnut Medical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		180 days	Yes
Secondary	Rate of complete target aneurysm occlusion		1, 3 and 5 years	No
Secondary	Incidence of ipsilateral major stroke		180 days	Yes
Secondary	Change in modified Rankin scale (MRS)		180 days, 1, 3 and 5 years	Yes
Secondary	Incidence of device-related adverse events		180 days, 1, 3 and 5 years	Yes
Secondary	Change from baseline in neurologic signs or symptoms related to the target aneurysm		180 days	No