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Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)

9 de abril de 2021 actualizado por: Svelte Medical Systems, Inc.

Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)

A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.

The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

159

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Hamburg, Alemania
        • University Medical Center Hamburg-Eppendorf
      • Hamburg, Alemania
        • Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer
  • Bélgica
      • Aalst, Bélgica
        • OLV Ziekenhuis Aalst
      • Antwerpen, Bélgica
        • Middelheim Ziekenhuis
      • Genk, Bélgica
        • ZOL Genk
      • Liege, Bélgica
        • CHU Liège
  • Chequia
      • Prague, Chequia
        • Vseobecna fakultni nemocnice Praha
  • Francia
      • Rouen, Francia
        • Clinique Saint-Hilaire
      • Toulouse, Francia
        • CHU de Toulouse
      • Toulouse, Francia
        • Clinique Pasteur
  • Países Bajos
      • Amsterdam, Países Bajos
        • OLVG Amsterdam
      • Eindhoven, Países Bajos
        • Catharina Hospital Eindhoven
      • Rotterdam, Países Bajos
        • Maasstad ziekenhuis
      • Rotterdam, Países Bajos
        • Erasmus MC
      • Utrecht, Países Bajos
        • University Medical Center Utrecht, Department of Cardiology
  • Suecia
      • Malmo, Suecia
        • Skane University Hospital
      • Stockholm, Suecia
        • Södersjukhuset
  • Suiza
      • Bern, Suiza
        • Inselspital

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

General Inclusion Criteria

  1. Patient is ≥18 years old;
  2. Patient is eligible for percutaneous coronary intervention (PCI);
  3. Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
  4. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
  5. Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure;
  6. Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site; and
  7. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.

Angiographic Inclusion Criteria

  1. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;

  2. If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:

    1. Residual diameter stenosis < 30%;
    2. Absence of any angiographic complications;
    3. Absence of ischemic symptoms; and
    4. Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischemia.
  3. Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;
  4. Target lesion < 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and
  5. Target lesion stenosis ≥ 50% and < 100% by visual estimate.

Exclusion Criteria:

General Exclusion Criteria

  1. Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;
  2. The patient requires a staged procedure of the target vessel within 6-months or a staged procedure of a non-target vessel within 30-days post-procedure;
  3. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.);
  4. Any DES deployment anywhere in the target vessel within the past 9-months;
  5. Any BMS deployment anywhere in the target vessel within the past 6-months;
  6. Any previous stent placement within 10 mm (proximal or distal) of the target lesion;

  7. Myocardial infarction within 72-hours of the index procedure, with the exception of:

    1. Patients who have had a STEMI and PCI to the culprit lesion may be included if they have a suitable lesion in another vessel, and have been clinically and hemodynamically stable for 72-hours;
    2. Patients who have had a non-STEMI may be included if their troponin levels are within the laboratory normal range within 24-hours pre-procedure.
  8. Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial;
  9. Concurrent medical condition with a life expectancy of less than 12-months;
  10. Documented left ventricular ejection fraction (LVEF) ≤ 30%;
  11. Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
  12. Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, Zotarolimus, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);
  13. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3.000 cells/mm3 or hemoglobin < 100g/l;
  14. Acute or chronic renal dysfunction (serum creatinine > 170μmol/L);
  15. History of a stroke or transient ischemic attack (TIA) within the prior 6-months;
  16. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months;
  17. History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and
  18. Patients requiring ongoing anticoagulation with warfarin or dabigatran.

Angiographic Exclusion Criteria

  1. Total occlusion (TIMI 0 or 1);
  2. Target vessel has angiographic evidence of thrombus
  3. Target vessel is excessively tortuous or has heavy calcification;
  4. Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
  5. Target lesion is located in or supplied by an arterial or venous bypass graft;
  6. Ostial target lesion (within 5.0 mm of vessel origin) or any location within the left main coronary artery;
  7. Target lesion involves a side branch > 2.0 mm in diameter; and
  8. Unprotected Left Main coronary disease (stenosis > 50%).

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Svelte Drug-Eluting Coronary Stent
Coronary Stenting
Dispositivo: Coronary Stenting
Comparador activo: Medtronic Resolute Integrity Drug-Eluting Stent
Coronary Stenting
Dispositivo: Coronary Stenting

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Angiographic In-Stent Late Lumen Loss (LL)
Periodo de tiempo: 6-months post-procedure
Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.
6-months post-procedure

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Clinically-driven Target Lesion Revascularization (TLR)
Periodo de tiempo: 1 year post-procedure
Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration.
1 year post-procedure
Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization
Periodo de tiempo: 1 year post-procedure
Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
1 year post-procedure
Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels
Periodo de tiempo: 1 year post-procedure
Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels
1 year post-procedure
Number of Participants Stent Thrombosis
Periodo de tiempo: 1 year post-procedure
The sudden occlusion of a stented coronary artery due to thrombus formation.
1 year post-procedure
Number of Participants Acute Success Rates
Periodo de tiempo: From index procedure to hospital discharge, an average of 24 hours
Direct Stenting Success, Lesion Success, Procedure Success and Device Failure
From index procedure to hospital discharge, an average of 24 hours
Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate
Periodo de tiempo: 6-months post-procedure
The rate which restenosis occurs
6-months post-procedure
In-stent and In-segment Minimum Lumen Diameter
Periodo de tiempo: 6-months post-procedure
Smallest diameter in the stent or segment area
6-months post-procedure
In-segment Late Lumen Loss
Periodo de tiempo: 6-months post-procedure
Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram
6-months post-procedure
Neointimal Hyperplasia as Measured by OCT
Periodo de tiempo: 6-months post procedures
(% lumen volume)
6-months post procedures
Strut Coverage
Periodo de tiempo: 6-months post procedure
(% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)
6-months post procedure
Number of Participants Target Vessel Failure
Periodo de tiempo: 1 year post procedure
Composite endpoint of cardiac death, target vessel MI (Q or Non-Q wave), or clinically- driven target vessel revascularization (TVR) by percutaneous or surgical methods.
1 year post procedure

Colaboradores e Investigadores

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

Patrocinador

Svelte Medical Systems, Inc.

Investigadores

  • Investigador principal: Alexandre Abizaid, MD, PhD, Instituto Dante Pazzanese de Cardiologia
  • Investigador principal: Stefan Verheye, MD, PhD, Antwerp Cardiovascular Institute

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

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 (Actual)

1 de enero de 2013

Finalización primaria (Actual)

1 de mayo de 2014

Finalización del estudio (Actual)

31 de mayo de 2019

Fechas de registro del estudio

Enviado por primera vez

5 de febrero de 2013

Primero enviado que cumplió con los criterios de control de calidad

7 de febrero de 2013

Publicado por primera vez (Estimar)

11 de febrero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de mayo de 2021

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

9 de abril de 2021

Última verificación

1 de abril de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IP-12-002

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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