Aneurysm Treatment Using Flow Diverter

Overview

About this study

The objectives of this study are to develop a repository of three-dimensional computerized tomography angiography (3DCTA) and three-dimensional rotational angiography (3DRA) imaging data and blood specimen collected from patients at pretreatment, post-treatment, and follow up, to monitor and identify the patients who have in-stent thrombosis, device mal-apposition, distal stroke, or other ischemic complications, to correlate fibrinogen levels, platelet activation, and thrombin generation with outcomes and to compare circulating miRNA and protein profiles and computational fluid dynamic (CFO) based hemodynamics and thrombosis initiation maker variables of patients who had ischemic complications versus those who did not.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Men or women.
  • 22 to 80 years old.
  • Unruptured cerebral aneurysm scheduled for flow diverter treatment at Mayo Clinic Rochester and Mayo Clinic Florida.
  • Patients who may require pre-treatment with Lorazepam/Ativan prior to MRI scanning provided they have an adult accompanying and driving for them after the scan is completed.

Exclusion Criteria:

  • IVC filter removal in last twelve months
  • Unable to have MRI imaging exams due to coil, filter, stent or wire or an implanted device such as IVC filter, pacemaker, nerve stimulator, medication pump or other on body injector delivery system/sensor or tattoo ink that if it contained metal could heat up and/or or generate image artifact.  Refer to form MC2609 Rev 0321 and consult with the MRI technician about any concern. 
  • Not able to return for follow-up MRI/MRA imaging and blood collection in three to twelve months post FD treatment.
  • Pregnant or breast-feeding females
  • Cancer diagnosis and having had (last twelve months) or currently undergoing radiation and/or chemotherapy treatments.
  • Prisoner

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/25/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ramanathan Kadirvel, Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Ana Lopez Reynoso

(507) 255-9846

LopezReynoso.Ana@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

William Fox, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available