Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device (PREMIER)

Study Name

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

Study Description

Intracranial Aneurysm

Condition

Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

Brief TitleShort description of the protocol intended for the lay public. Include a brief statement of the study hypothesis.

This study has suspended participant recruitment.

Recruitment StatusIndicates the current stage of a clinical study and whether it is or will be open for enrollment.

Medtronic Neurovascular Clinical Affairs

SponsorThe sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medtronic Neurovascular Clinical Affairs

Information provided byThe contents of the study record are provided by this organization or person. This sponsor, sponsor-investigator, or sponsor-designated principal investigator is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information.

NCT02186561

ClinicalTrials.gov IdentifierA unique identification code is given to each clinical study registered on ClinicalTrials.gov. Because the format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419), this identifier is also known as the NCT Number.

First ReceivedThe First Received date is the date that summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry.

Last UpdatedThe Last Updated date is the most recent date that changes to a study record were submitted to ClinicalTrials.gov.

December 2019

Last VerifiedThe Last Verified date is the most recent date that all of a clinical study's information on ClinicalTrials.gov was confirmed as accurate and current.

First Received DateThe First Received date is the date that summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry.

Last Updated DateThe Last Updated date is the most recent date that changes to a study record were submitted to ClinicalTrials.gov.

July 24, 2014

Start DateThe date that the enrollment of participants for a clinical study begins

December 13, 2018

Estimated Primary Completion Date The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.

• The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure [ Time Frame: Up to 12 Months Post Procedure ] [ Designated as safety issue:  ]
  The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.

• The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure [ Time Frame: Up to 12 Months Post Procedure ] [ Designated as safety issue:  ]
  The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.

Current Primary Outcome Measures Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.

Same as current

Original Primary Outcome Measures Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.

Click [ HERE ] for a complete list of historical versions of study NCT02186561 on ClinicalTrials.gov Archive Site

Change Historyclick the link provided for a complete list of historical versions of study NCT02186561 on ClinicalTrials.gov Archive Site.

• The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications [ Time Frame: Up to 30 days, Post Procedure ] [ Designated as safety issue:  ]Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.

• The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure [ Time Frame: > 30 days, Post Procedure ] [ Designated as safety issue:  ]For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.

• The Number of Participants With Successfully Deployed Investigational Device [ Time Frame: Index Procedure ] [ Designated as safety issue:  ]The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.

Current Secondary Outcome Measures Secondary measurements that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue as described above.

Same as current.

Original Secondary Outcome MeasuresSecondary measurements that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue as described above.

Current Other Outcome MeasuresAny other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue.

Not Provided

Original Other Outcome MeasuresAny other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue.

Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

Brief TitleProtocol title intended for the lay public.

Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)

Official TitlesOfficial name of the protocol provided by the study principal investigator or sponsor.

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

Brief SummaryShort description of the protocol intended for the lay public. Include a brief statement of the study hypothesis.

Not Provided

Detailed DescriptionExtended description of the protocol, including more technical information.

Interventional

Study TypeInterventional study in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.

Observational study in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Expanded Access records describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track.

Study DesignTOOLTIP TOO ELABORATE

Target Follow-Up DurationFor Patient Registries, the anticipated time period over which each participant is to be followed. Provide a number and select a unit of time (years, months, weeks, days).

False

BiospecimenuSpecify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue).

Intracranial Aneurysm

ConditionPrimary disease or condition being studied, or focus of the study. Diseases or conditions should use the National Library of Medicine's Medical Subject Headings (MeSH) controlled vocabulary when possible.

Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device

InterventionFor all studies, and for expanded access records, specify the associated intervention(s). For interventional studies, at least one intervention must be specified. For observational studies, specify the intervention(s)/exposure(s) of interest, if any.

This study has suspended participant recruitment.

Recruiting StatusTOOLTIP TOO COMPLEX TO DISPLAY

197

Estimated EnrollmentNumber of subjects in the trial.

December 13, 2018

Completion DateFinal date on which data was (or is expected to be) collected.

November 18, 2016

Estimated Primary Completion DateThe date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.

Inclusion Criteria: 1. Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements. 2. Age 22-80 years. 3. Subject has a target intracranial aneurysm (IA) located in the: 1. Internal carotid artery (up to the carotid terminus) OR 2. Vertebral artery segment up to and including the posterior inferior cerebellar artery 4. Subject has a target IA that is ≤ 12 mm. 5. Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA. 6. Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5. 7. Subject has a pre-procedure PRU value between 60-200. Exclusion Criteria: 1. Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks. 2. Subarachnoid hemorrhage in the past 30 days. 3. Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy. 4. Major surgery in the last 30 days. 5. History of irreversible bleeding disorder and/or subject presents with signs of active bleeding. 6. Any known contraindication to treatment with the Pipeline™ device, including: 1. Stent is in place in the parent artery at the target IA location 2. Contraindication to dual antiplatelet therapy 3. Relative contraindication to angiography (e.g., serum creatinine >2.5 mg/dL, allergy to contrast that cannot be medically controlled). 4. Known severe allergy to platinum or cobalt/chromium alloys. 5. Evidence of active infection at the time of treatment (e.g., fever with temperature >38°C and/or WBC >1.5 109/L). 7. The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment. 8. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation. 9. Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.

Eligibility CriteriaPhysical gender of individuals who may participate in the protocol.

Minimum and/or maximum age of participants.

Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study.

All

GenderBoth: both female and male participants are being studied

Female: only female participants are being studied

Male: only male participants are being studied

Minimum Age: 22 Years | Maximum Age: 80 Yearsyrs

AgesMinimum Age
Definition: Minimum age of participants. Provide a number and select a unit of time (years, months, weeks, days, hours or minutes). Select "N/A (No limit)" if no minimum age is indicated.

Maximum Age
Definition: Maximum age of participants. Provide a number and a unit of time (years, months, weeks, days, hours or minutes). Select "N/A (No limit)" if no maximum age is indicated.

No

Accepts Healthy VolunteersAccepts Healthy Volunteers

ContactsCentral Contact - Person providing centralized, coordinated recruitment information for the entire study.
Central Contact Backup - Person to contact if Central Contact is not available.
Overall Study Officials - Person(s) responsible for the overall scientific leadership of the protocol, including study principal investigator.

Canada, United States

Listed Location CountriesDESCRIPTION

Removed CountriesDESCRIPTION

NCT02186561

NCT NumberA unique identification code is given to each clinical study registered on ClinicalTrials.gov. Because the format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419), this identifier is also known as the NCT Number.

NV-PED-07

Other Study ID NumbersUnique identification assigned to the protocol by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number.

No

Has Data Monitoring CommitteeGGGGGGG

Medtronic Neurovascular Clinical Affairs

Responsible PartySponsor: the entity (e.g., corporation or agency) that initiates the study
Principal Investigator: the individual who serves as the principal investigator and is designated as responsible party, consistent with the conditions described in the statute Sponsor-Investigator: the individual who both initiates and conducts the study

CollaboratorA collaborator is an organization other than the sponsor that provides support for a clinical study. This may include funding, design, implementation, data analysis, or reporting.

PrincipalInvestigator: Ricardo Hanel, M.D. | Baptist Medical Center

InvestigatorsThe person who both initiates and conducts the clinical study.

Medtronic Neurovascular Clinical Affairs

Information Provided ByThe contents of the study record are provided by this organization or person. This sponsor, sponsor-investigator, or sponsor-designated principal investigator is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information.

December 2019

Verification DateDate the protocol information was last verified. Verification date is shown along with organization name on ClinicalTrials.gov to indicate to the public whether the information is being kept current, particularly recruiting status and contact information.