- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05391815
This Study is a Prospective, Multi-center, Real World, Observational Study, Which Aims at Evaluating Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease.
Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
In the past decade, endovascular treatment has become the first-line treatment for iliac artery occlusion, while Aorta - bilateral femoral artery bypass surgery is preferred for more complex iliac artery occlusion. However, recently, with advances in endovascular devices and techniques, endovascular interventions have gradually replaced open surgery in many clinical problems and have shown ideal safety and efficacy.
Currently, the optimal treatment for TASC, C&D iliac artery occlusion is controversial, mostly based on limited data from single centers and few large multicenter databases or registries. In addition, the long-term efficacy of stents implantation in iliac artery disease remind unknown and might be influenced by stent type and calcification. Therefore, the purpose of this study was to evaluate the long-term efficacy and safety of endovascular treatment for TASC, C&D iliac artery occlusion in a multicenter study.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zhenyu Shi, MD,PhD
- Número de teléfono: +86021-64041990
- Correo electrónico: shizhenyumax@163.com
Ubicaciones de estudio
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Shanghai, Porcelana
- Reclutamiento
- Zhongshan Hospital, Fudan University
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Contacto:
- Zhenyu Shi, MD, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Rutherford grades 3-6.
- Follow the follow-up arrangement.
- Age: 18-80 years old.
- The target lesions were in the lower abdominal aorta and/or the common iliac artery and/or the external iliac artery.
- The stenosis degree ≥50%, or restenosis (received PTA or other adjuvant therapy, including bare or covers stents), or complete occlusion, or the presence of aortailiac artery thrombosis after PMT or CDT thrombus clearance, and then further endovascular therapy perfomred.
- Signed informed consent.
Exclusion Criteria:
- Known allergy to drugs used in this study, including antiplatelet or anticoagulant drugs, etc.
- Allergy to iodine contrast agent allergy;
- Coagulation dysfunction or hypercoagulability;
- Breast-feeding or pregnant women;
- Life expectancy < 24 months;
- Body condition can not tolerate endovascular treatment;
- Type 2B, type 3 lower limb ischemia patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Freedom from clinically-driven TLR
Periodo de tiempo: 60 months
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CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms.
Freedom form CD-TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.
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60 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidencia de eventos adversos mayores.
Periodo de tiempo: 1 mes, 3 meses, 6 meses, 12 meses, 24 meses
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Los eventos adversos mayores incluyen cualquiera de los siguientes: mortalidad por todas las causas, infarto de miocardio, accidente cerebrovascular isquémico, isquemia aguda de las extremidades y amputación mayor de etiología vascular y trombosis arterial relacionada con la manipulación endovascular.
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1 mes, 3 meses, 6 meses, 12 meses, 24 meses
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Technical success rate
Periodo de tiempo: 30 days
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We defined the technical success rate as the rate of patients in whom the endovascular treatments are successfully performed.
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30 days
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Adverser events related to insufficient lower limb blood supply.
Periodo de tiempo: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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Major amputation, acute re-occlusion, subacute re-occlusion and chronic re-occlusion.
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1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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CD-TLR
Periodo de tiempo: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
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CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms.
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1 month, 3 months, 6 months, 12 months, 24 months, 36 months
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Vascular quality of life questionnaire(VascuQol)
Periodo de tiempo: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL).
Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.
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1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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Health economics evaluation
Periodo de tiempo: 60 months
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All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.
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60 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Stoner MC, Calligaro KD, Chaer RA, Dietzek AM, Farber A, Guzman RJ, Hamdan AD, Landry GJ, Yamaguchi DJ; Society for Vascular Surgery. Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease. J Vasc Surg. 2016 Jul;64(1):e1-e21. doi: 10.1016/j.jvs.2016.03.420.
- Indes JE, Pfaff MJ, Farrokhyar F, Brown H, Hashim P, Cheung K, Sosa JA. Clinical outcomes of 5358 patients undergoing direct open bypass or endovascular treatment for aortoiliac occlusive disease: a systematic review and meta-analysis. J Endovasc Ther. 2013 Aug;20(4):443-55. doi: 10.1583/13-4242.1.
- Hajibandeh S, Hajibandeh S, Antoniou SA, Torella F, Antoniou GA. Covered vs Uncovered Stents for Aortoiliac and Femoropopliteal Arterial Disease: A Systematic Review and Meta-analysis. J Endovasc Ther. 2016 Jun;23(3):442-52. doi: 10.1177/1526602816643834. Epub 2016 Apr 20.
- Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
- Tshomba Y, Melissano G, Apruzzi L, Baccellieri D, Negri G, Chiesa R. Open repair for aortic occlusive disease: indication, techniques, results, tips and tricks. J Cardiovasc Surg (Torino). 2014 Apr;55(2 Suppl 1):57-68.
- Kashyap VS, Pavkov ML, Bena JF, Sarac TP, O'Hara PJ, Lyden SP, Clair DG. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg. 2008 Dec;48(6):1451-7, 1457.e1-3. doi: 10.1016/j.jvs.2008.07.004. Epub 2008 Sep 19.
- Dorigo W, Piffaretti G, Benedetto F, Tarallo A, Castelli P, Spinelli F, Fargion A, Pratesi C. A comparison between aortobifemoral bypass and aortoiliac kissing stents in patients with complex aortoiliac obstructive disease. J Vasc Surg. 2017 Jan;65(1):99-107. doi: 10.1016/j.jvs.2016.06.107. Epub 2016 Sep 12.
- Rzucidlo EM, Powell RJ, Zwolak RM, Fillinger MF, Walsh DB, Schermerhorn ML, Cronenwett JL. Early results of stent-grafting to treat diffuse aortoiliac occlusive disease. J Vasc Surg. 2003 Jun;37(6):1175-80. doi: 10.1016/s0741-5214(03)00326-4.
- Hans SS, DeSantis D, Siddiqui R, Khoury M. Results of endovascular therapy and aortobifemoral grafting for Transatlantic Inter-Society type C and D aortoiliac occlusive disease. Surgery. 2008 Oct;144(4):583-9; discussion 589-90. doi: 10.1016/j.surg.2008.06.021.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- The ALLIANCE Study
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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