ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

CompletadoClinicalTrials.gov

ID: NCT01023789Tipo: INTERVENTIONALInicio: 1 de ene de 2010Fin estimado: 1 de oct de 2016

Traducción no disponible, mostrando original

Resumen

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1.
Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
Percutaneous intervention for lesions in the target vessel are allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure.

Criterios de exclusión

Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation.
Total occlusion (TIMI flow 0), prior to wire passing.
Target vessel(s) contains visible thrombus.
Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
Subject has received brachytherapy in any epicardial vessel (including side branches).

Intervenciones

device

ABSORB BVS

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

Ubicaciones

Instituto Cardiovascular de Buenos Aires-ICBA

Buenos Aires, Argentina

Patrocinadores

PrincipalAbbott Medical Devices

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

ABSORB EXTEND Clinical Investigation: A Continuation in t... | EligiMed