Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
246 participants
OBSERVATIONAL
2021-12-20
2028-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
NCT01811134
Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
NCT00233753
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
NCT00231231
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
NCT00288405
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
NCT00403078
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S.
This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Treatment of Intracranial Aneurysms
Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient is intended to receive or be treated with an eligible Medtronic product.
3. Patient is consented within the enrollment window of the therapy received, as applicable.
4. Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR).
5. Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU).
Exclusion Criteria
2. Participation is excluded by local law.
3. Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness).
4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
5. Patient is contraindicated for the device or procedure per the Pipeline™ Shield Device IFU.
6. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
7. Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic.
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harsh Sancheti
Role: STUDY_DIRECTOR
Medtronic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Endeavor Health - Evanston Hospital
Evanston, Illinois, United States
Norton Healthcare
Louisville, Kentucky, United States
Washington University in Saint Louis
St Louis, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma (OU) University Medical Center
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDT16056 (Shield PAS)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.