Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
A legfontosabb adatok
- Ki végzi
- W.L.Gore & Associates
- Hol
- Belgium, Egyesült Királyság, Franciaország, Görögország, Hollandia, Németország, Olaszország, Spanyolország és Svédország26 helyszín, 9 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Fut, nem toboroz
- Résztvevők
- 614 fő, tervezett
- Kezdés
- 2021. okt. 9.
- Várható befejezés
- 2035. okt.
- A vizsgálat típusa
- Megfigyeléses, 8 csoport
- A vizsgált kezelések
- GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- A regiszteradat frissítve
- 2026. augusztus 20.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 16 feltétel megnézéseKevesebb
Ki vehet részt
- Age ≥ 18 years
- Signed informed consent form
- Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
- Willingness of the patient to adhere to institutional standard of care follow-up requirements
Ki nem vehet részt
- Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU)
- Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system)
- Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort)
- Participation in concurrent research study or registry which may confound registry results, unless approved by Gore
- Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II
- Unable to tolerate antiplatelet therapy
- Patient has a non-controllable allergy to contrast or the VSX Device components
- Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders)
- Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system
- Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis
- Pregnant or breast-feeding female at time of informed consent signature
- Life expectancy < 12 months due to comorbidities
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
9 országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
A vizsgálat 8 csoportja
- Iliac
Subjects with de novo or restenotic lesions in the iliac arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Kezelés: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Superficial Femoral Artery (SFA)
Subjects with de novo or restenotic lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Kezelés: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Superficial Femoral Artery (SFA) In-Stent Restenosis (ISR)
Subjects with in-stent restenosis lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Kezelés: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- AV access
Subjects with stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft and in the venous outflow of dialysis access circuits, including the central veins treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Kezelés: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Popliteal Artery Aneurysms
Subjects with popliteal artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Kezelés: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Trauma/Injury
Subjects with traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Kezelés: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Visceral Artery Aneurysms
Subjects with isolated visceral artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Kezelés: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Others
Subjects treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) but do not fit any of the cohorts listed above.
Kezelés: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
- A regiszteradat frissítve
- 2026. augusztus 20.