Framing Eighteen Coils in Cerebral Aneurysms Trial
A legfontosabb adatok
- Ki végzi
- Vanderbilt University Medical Center
- Hol
- Buffalo, Charleston, Chattanooga, Cincinnati, Columbus, Dallas, Englewood, Fresno, Gainesville, Greenville, Jackson, Knoxville, Lexington, Memphis, Morgantown, Nashville, New York, North Worcester, Richmond, Stony Brook, Tampa és Winston-Salem (Egyesült Államok)Mind a 24 helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 651 fő vett részt
- Kezdés
- 2012. dec. 4.
- Befejezés
- 2024. febr. 19.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Coil Embolization with larger Diameter Coils
- Coil Embolization with Standard Diameter Coils
- A regiszteradat frissítve
- 2025. február 6.
Ki vehet részt
- Életkor
- 18 év – 80 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular treating team (neurointerventionist and/or neurosurgeon)
- The neurointerventionist feels that the aneurysm can be safely treated with either using, or not using, a 0.015-0.0155" platinum coil
- Patients are 18-80 years of age (inclusive)
- Patient must be Hunt and Hess grade 0 to 3
- Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney
- Aneurysm 6-14 mm in maximum diameter
- Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at 3-6 months and 12-18 months after endovascular treatment
- The patient has not been previously randomized into this trial or another related ongoing trial
- The aneurysm has not been previously treated by coiling or clipping
Ki nem vehet részt
- Target aneurysm has had previous coil treatment or has been surgically clipped
- Medical or surgical co-morbidity such that the patient's life expectancy is less than 2 years
- Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage
- Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the FEAT inclusion criteria (ie - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses)
- Inability to obtain informed consent
Helyszínek itt: Egyesült Államok
- University of BuffaloBuffalo, Egyesült ÁllamokNo longer taking part
- Medical Center of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
- Tennessee Interventional Associates - ErlangerChattanooga, Egyesült ÁllamokNo longer taking part
- Mayfield ClinicCincinnati, Egyesült ÁllamokNo longer taking part
- Ohio State UniversityColumbus, Egyesült ÁllamokNo longer taking part
- University of Texas, SouthwesternDallas, Egyesült ÁllamokNo longer taking part
- Colorado Neurological InstituteEnglewood, Egyesült ÁllamokNo longer taking part
- Radiology Imaging AssociatesEnglewood, Egyesült ÁllamokNo longer taking part
- UCSF-Fresno, Community Regional Medical CenterFresno, Egyesült ÁllamokNo longer taking part
- University of FloridaGainesville, Egyesült ÁllamokNo longer taking part
- Prisma HealthGreenville, Egyesült ÁllamokNo longer taking part
- University of MississippiJackson, Egyesült ÁllamokNo longer taking part
- Fort Sanders Regional Medical CenterKnoxville, Egyesült ÁllamokNo longer taking part
- University of Tennessee Medical Center KnoxvilleKnoxville, Egyesült ÁllamokNo longer taking part
- University of KentuckyLexington, Egyesült ÁllamokNo longer taking part
- Methodist University HospitalMemphis, Egyesült ÁllamokNo longer taking part
- West Virginia University HospitalMorgantown, Egyesült ÁllamokNo longer taking part
- Vanderbilt University Medical CenterNashville, Egyesült ÁllamokNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, Egyesült ÁllamokNo longer taking part
- University of Massachusetts Medical SchoolNorth Worcester, Egyesült ÁllamokNo longer taking part
- Virginia Commonwealth UniversityRichmond, Egyesült ÁllamokNo longer taking part
- Stony Brook UniversityStony Brook, Egyesült ÁllamokNo longer taking part
- University of South Florida - Tampa GeneralTampa, Egyesült ÁllamokNo longer taking part
- Wake Forest Baptist HealthWinston-Salem, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter).
A teljes eredeti leírásKevesebb
Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.
A vizsgálat 2 csoportja
- Eighteen Coils (0.014-0.0155 inch)Már használt kezelés, összehasonlításként
Subjects who randomize to this arm will receive larger diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target XL 360 Standard, Target XL 360 Soft, Target XL 360 Helical, GDC-18 360 Standard, GDC-18 3D, GDC-18 2D, GDC-18 Soft, and/or 0.014-0.0155 inch diameter bare platinum intracranial coils.
Kezelés: Coil Embolization with larger Diameter Coils
- Standard Coils (0.014 inch)Már használt kezelés, összehasonlításként
Subjects who randomize to this arm will receive the standard diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target 360 Standard, Target 360 Soft, Target 360 Ultra, Target 360 NANO, Target 360 Helical Ultra, GDC-10 360 Standard SR, GDC-10 360 Soft SR, GDC-10 UltraSoft, GDC-10 3D, GDC-10 2D, GDC-10 Soft 2D SR, GDC-10 Soft SR, GDC-10 Soft, and/or any additional 0.014 inch or less diameter bare platinum intracranial coils.
Kezelés: Coil Embolization with Standard Diameter Coils
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT
- A regiszteradat frissítve
- 2025. február 6.