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Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms (PEDVU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05626504
Recruitment Status : Active, not recruiting
First Posted : November 23, 2022
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Tracking Information
First Submitted Date November 1, 2022
First Posted Date November 23, 2022
Last Update Posted Date March 5, 2024
Actual Study Start Date October 27, 2022
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2022)
  • Evaluate 30-day morbidity rates [ Time Frame: Done at 30 days post procedural ]
    We will evaluate short term clinical outcome in the form of morbidity rates 30 days after the procedure
  • Evaluate 30-day mortality rates [ Time Frame: Done at 30 days post procedural ]
    We will evaluate short term clinical outcome in the form of mortality rates 30 days after the procedure
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 22, 2022)
  • Evaluate 1-year morbidity rates [ Time Frame: Done at >30days up to 1 year post procedural ]
    We will evaluate long term clinical outcome in the form of morbidity rates >30days up to 1 year after the procedure
  • Evaluate 1-year mortality rates [ Time Frame: Done at >30days up to 1 year post procedural ]
    We will evaluate long term clinical outcome in the form of mortality rates >30days up to 1 year after the procedure
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
Official Title Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
Brief Summary In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients Treated with pipeline embolization devices during 2021 and 2022
Condition
  • Brain Aneurysm
  • Intracranial Hemorrhages
  • Stroke
Intervention Device: Pipeline Embolization Device with Vantage Technology
Flow-diverter device occludes aneurysms through endoluminal reconstruction and remodelling of the parent artery.
Study Groups/Cohorts Not Provided
Publications * Atasoy D, Kandasamy N, Hart J, Lynch J, Yang SH, Walsh D, Tolias C, Booth TC. Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU). AJNR Am J Neuroradiol. 2019 Dec;40(12):2094-2101. doi: 10.3174/ajnr.A6314. Epub 2019 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 22, 2022)		 50
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2025
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)
  • MRA and/or DSA (or tomographic angiography) available for follow up

Exclusion Criteria:

  • Insufficient background data available e.g., to determine size of aneurysm and pipeline device
  • PEDV used for causes other than aneurysms, e.g., fistulas and dissection.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT05626504
Other Study ID Numbers 317314
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Current Responsible Party King's College Hospital NHS Trust
Original Responsible Party Same as current
Current Study Sponsor King's College Hospital NHS Trust
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account King's College Hospital NHS Trust
Verification Date March 2024