A new endoluminal, flow-disrupting device for treatment of saccular aneurysms.
David F Kallmes, Yong Hong Ding, Daying Dai...
https://pubmed.ncbi.nlm.nih.gov/17615366Actively Recruiting
Age: 18Years +
All Genders
ID06201598
Prospective, Single-Arm, Multicenter Study Evaluating Safety and Effectiveness of P64 and P48 Flow-Diverter Stents for Cerebral Aneurysms
Led by Hospital Universitario Central de Asturias · Updated on 2024-11-22
100
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of flow-diverting stents, specifically the p64MW HPC and p48MW HPC devices, for treating cerebral aneurysms. These devices have a coating designed to reduce the risk of blood clots, which can be a complication of this treatment. The study is observational and takes place in routine clinical settings across several Spanish hospitals to assess the effectiveness and safety of these devices over a one-year period. The study involves endovascular treatment where the flow-diverting stents are implanted to treat intracranial aneurysms or dissections. These devices have a hydrophilic polymer coating aimed at lowering thromboembolic complications. The study collects data during the procedure and continues with clinical and radiological follow-ups over twelve months to monitor outcomes and complications. Participants will undergo assessments to evaluate intervention success, thromboembolic and hemorrhagic complications, mortality, and clinical progression using scales such as the NIH Stroke Scale and Modified Rankin Scale. Additional monitoring includes imaging to evaluate aneurysm occlusion and ischemic complications at six months and one year. The total participation involves follow-ups for up to one year to measure both effectiveness and safety outcomes.
CONDITIONS
Brief Title
Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms
- Signed informed consent by the patient or their representative
You will not qualify if you...
- Patients under 18 years of age
- Absence of signed informed consent by the patient or their representative
- Known, medically untreatable allergy to iodinated contrast
- Pregnant women or those breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of procedure
Participants undergo endovascular treatment for cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC flow-diverting devices as part of routine clinical practice.
1 visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants are monitored for clinical and radiological outcomes related to the treatment, including safety and effectiveness assessments over 12 months.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 11 locations
1
Hospital Universitario de A Coruña
A Coruña, Spain, 15006
Actively Recruiting
2
Hospital Universitari Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
3
Hospital Universitari Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
4
Hospital Universitario de Burgos
Burgos, Spain, 09006
Actively Recruiting
5
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain, 20014
Actively Recruiting
6
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
7
Hospital Regional Universitario de Malaga
Málaga, Spain, 29010
Actively Recruiting
8
Hospital Universitario Central de Asturias
Oviedo, Spain, 33006
Actively Recruiting
9
Hospital Parc Tauli
Sabadell, Spain, 08208
Actively Recruiting
10
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47003
Actively Recruiting
11
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
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Research Team
P
PEDRO VEGA VALDES, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Cellular mechanisms of aneurysm occlusion after treatment with a flow diverter.
Ramanathan Kadirvel, Yong-Hong Ding, Daying Dai...
https://pubmed.ncbi.nlm.nih.gov/24086073Comparison of intra-aneurysmal flow modification using optical flow imaging to evaluate the performance of Evolve and Pipeline flow diverting stents.
Nicole Mariantonia Cancelliere, Patrick Nicholson, Ivan Radovanovic...
https://pubmed.ncbi.nlm.nih.gov/32317371Variable porosity of the pipeline embolization device in straight and curved vessels: a guide for optimal deployment strategy.
M Shapiro, E Raz, T Becske...
https://pubmed.ncbi.nlm.nih.gov/24072622p64 Flow Modulation Device in the treatment of intracranial aneurysms: initial experience and technical aspects.
Francesco Briganti, Giuseppe Leone, Mariano Marseglia...
https://pubmed.ncbi.nlm.nih.gov/25895510Initial Experience with p64: A Novel Mechanically Detachable Flow Diverter for the Treatment of Intracranial Saccular Sidewall Aneurysms.
S Fischer, M Aguilar-Pérez, E Henkes...
https://pubmed.ncbi.nlm.nih.gov/26272970Endovascular treatment of intracranial aneurysms with the p64 flow diverter stent: mid-term results in 35 patients with 41 intracranial aneurysms.
Ricardo Morais, Benjamin Mine, Pierre Julien Bruyère...
https://pubmed.ncbi.nlm.nih.gov/28236050Mid-term and long-term follow-up of intracranial aneurysms treated by the p64 Flow Modulation Device: a multicenter experience.
Francesco Briganti, Giuseppe Leone, Lorenzo Ugga...
https://pubmed.ncbi.nlm.nih.gov/27439887Endovascular Treatment of Anterior Circulation Aneurysms With the p64 Flow Modulation Device: Mid- and Long-Term Results in 617 Aneurysms From a Single Center.
Marta Aguilar Pérez, Elina Henkes, Victoria Hellstern...
https://pubmed.ncbi.nlm.nih.gov/33469666p64 flow diverter: Results in 108 patients from a single center.
Tom De Beule, T Boulanger, S Heye...
https://pubmed.ncbi.nlm.nih.gov/32506988