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Polymer Free Stent in Acute Coronary Syndrome

4 de abril de 2019 actualizado por: Ahmed Samir Ali Mahfouz, Assiut University

Polymer Free Drug Eluting Stent in Non ST Elevation Acute Coronary Syndrome

To evaluate the short term out comes of the polymer free stents in patients presented with non ST elevation acute coronary syndrome (which include ST depression myocardial infarction and unstable angina ) after percutaneous coronary intervention .

Descripción general del estudio

Descripción detallada

One of the treatment options for CAD is a percutaneous coronary intervention through balloon angioplasty or stent insertion . Although the restenosis rate can be reduced by using bare metal stents , the in-stent restenosis (ISR) rate is still high at around 20%-30% .

increased rates of stent thrombosis were reported with first-generation DESs.(5) The high rate of late and very late stent thrombosis is caused by a long duration of drug elution, which can delay endothelial healing and prolong metallic structure exposure to blood vessel .

Conventionally, DES (drug eluting stents ) are coated with permanent polymers that facilitate drug release and remain long after drug elution is complete. These permanent polymers can cause delayed healing, impaired stent strut endothelialization , and a hypersensitivity reaction, which can culminatein ST (stent thrombosis ).

Research has led to the design of the newer DES (drug eluing stents) that have biodegradable polymers, novel coatings, or are completely polymer free. The polymer-free technology has the potential advantage to reduce the inflammatory and prothrombotic risks related to the utilization of polymers .

  • Our study will be conducted on at least thirty patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS)who will be subjected to the early invasive strategy . Polymer-free drug eluting stents will be used for these patients instead of the usually used polymer-permanent drug eluting stents .
  • Patients with NST-ACS who will meet the inclusion and exclusion criteria will be subjected to the following during the admission in the ICU :
  • History of the patient concerning :
  • Analysis of presenting complaint . Past history of previous similar complaints or the coarse of his illness if he is known to have IHD(ischemic heart disease ) before . Risk factors ( Diabetus mellitus , hypertension , smoking ,....) .Any other co-morbidities and therapeutic history .
  • Examination will be done with special concern payied for:
  • Blood pressure, heart rate, respiratory rate, Jugular Venous Pressure (JVP), cardiac examination and chest auscultation .
  • Investigations in the form of:
  • Serial 12 lead ECG .
  • Laboratory investigations : (Complete Blood Count (CBC) , Prothrombine time and concentration ,Kidney function ,HCV-Ab , HBs-Ag , HIV Ab , Creatine kinase (CK and CK-MB ) and Troponin at admission and 6 hours later ) .
  • Imaging:
  • Echocardiographic evaluation with certain emphasis on the following parameters (Wall motion abnormalities ,systolic function , diastolic function and cardiac dimensions).
  • TIMI (Thrombolysis in Myocardial Infarction ) risk score will be calculated to every patient .
  • Each of the following criteria constitutes one point for TIMI scoring :
  • Age ≥65 years
  • Three or more risk factors for coronary artery disease (CAD) (family history of CAD, hypertension, hypercholesterolemia, diabetes mellitus, tobacco use)
  • Known CAD (stenosis >50%)
  • Aspirin use in the past 7 days
  • Severe angina (≥2 episodes in 24 hours)
  • ST deviation ≥0.5 mm
  • Elevated cardiac marker level
  • Syntax score will be caiculated during PCI .
  • Early invasive strategy with percutaneous coronary intervention will be done for these patients using Polymer-free drug eluting stents instead of the polymer-permanent drug eluting stents .
  • The patients will be followed for 6 months after the intervention .
  • The patients included in the study will be followed up and re-evaluated at one month and six months after the intervention ( by telephon calls and office visits )
  • Re-evaluation will include asking about and analysing symptoms of IHD after the PCI , compliance to the medications .
  • Examination: Vital signs , JVP , chest and heart examination .
  • 12-lead ECG and cardiac enzymes if needed .
  • Follow up Echocardiography will be done at six months .
  • Patients will be subjected to follow up diagnostic coronary angiography six months of PCI (whenever possible).
  • Six months views after the index procedure coronary angiography will be evaluated by quantitative coronary angiography (QCA) with edge detection method used for evaluation of coronary lesion in index and follow up procedures. Minimal luminal diameter (MLD), Reference vessel diameter (RVD), Percent diameter stenosis %DS), Acute Gain, Late loss and Late loss index will be estimated.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

30

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients from 18 to 85 years of both genders presented with NSTE-ACS with TIMI score ( ≥ 3), who will be subjected to early invasive strategy, whose coronary angiography shows de novo coronary artery disease (CAD) with a stenotic lesion ≥ 70 % requiring use of 2 stents or less.

Exclusion Criteria:

  • • Patients with NSTEACS who will be subjected to conservative strategy.

    • Patients whose coronary angiography shows CAD with significant lesions not candidate for PCI like target lesion location in the left main stem or multi vessel disease .
    • In-stent restenosis .
    • Stenosis in bypass graft .
    • Raised renal chemistry (serum creatinine > 2 mg/dl) .
    • Known allergy to the contrast media or other medications used during and after percutaneous coronary intervention .
    • Contraindication to antiplatelet (Asprin, Clopidogrel) or heparin therapy e.g. significant external or internal bleeding and active peptic ulcer .
    • Severly impaired LV systolic function (LVEF < 35%).
    • Malignancies or other co-morbid conditions (for example, severe liver, renal, and pancreatic disease) with life expectancy<6 months or that may result in protocol non-compliance .
    • Pregnancy .
    • Previous enrolment in this trial

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Invasive Strategy group
  • Our study will be conducted on at least thirty patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS)-which include ST depression myocardial infarction and unstable angina- who will be subjected to the early invasive strategy . Polymer-free drug eluting stents will be used for these patients instead of the usually used polymer-permanent drug eluting stents .
• Early invasive strategy with percutaneous coronary intervention will be done for the patients presenting with NST ACS who meet the inclusion criteria using Polymer-free drug eluting stents instead of the polymer-permanent drug eluting stents .

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
• Major adverse cardiac events (MACE)
Periodo de tiempo: During six months after the intervention .
  • Recurrent angina pectoris, post-infarction angina, new or recurrent myocardial infarction.
  • Target lesion revascularization (TLR).
  • Target vessel revascularization (TVR).
  • Left ventricular dysfunction.
  • Cardiac arrhythmias.
  • Cardiac death.
During six months after the intervention .
Mortality rate
Periodo de tiempo: Within six months of the intervention
Mortality rate in patients underwent the intervention
Within six months of the intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
• Instent restenosis
Periodo de tiempo: six months after the intervention
defined as > 50% instent diameter restenosis on the follow up coronary angiogram.
six months after the intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de agosto de 2019

Finalización primaria (Anticipado)

1 de septiembre de 2021

Finalización del estudio (Anticipado)

1 de noviembre de 2021

Fechas de registro del estudio

Enviado por primera vez

15 de marzo de 2019

Primero enviado que cumplió con los criterios de control de calidad

15 de marzo de 2019

Publicado por primera vez (Actual)

18 de marzo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de abril de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

4 de abril de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • polymer free stent

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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