Evaluación de seguridad y eficacia del stent cubierto iCover para el tratamiento de la enfermedad oclusiva aorto-ilíaca (iliCo)
Estudio observacional prospectivo, multicéntrico, no aleatorizado, de un solo grupo para evaluar la seguridad y la eficacia del stent cubierto con iCover para el tratamiento de la enfermedad oclusiva aortoilíaca
The objective of this prospective, multi-center, non-randomized, single-arm observational study is to evaluate the safety and the efficacy of the iCover covered stent over a 24-month follow-up period for the treatment of de novo iliac occlusive lesions, defined by a significant vessel stenosis ≥70%, in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, single-arm, multinational, and multicenter study conducted to evaluate the safety and efficacy of the iCover covered stent for the treatment of de novo iliac occlusive lesions (common and/or external iliac arteries) in patients with symptomatic lower limb arteriopathy. The primary endpoint of the study is primary patency, defined as the absence of restenosis in the target lesion over a 12-month follow-up period in patients who did not undergo a reintervention on the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, assessed either by duplex ultrasound (considered as a peak systolic velocity index ≥ 2.4 at the target lesion) or by angio-CT (multiplanar reconstruction). Secondary endpoints include: technical and procedural success rate, freedom from all major adverse events, incidence of procedure- or device-related major local complications at the treated lesion, rate of SAEs, major amputation rate at the target limb, primary sustained clinical improvement (improvement in Rutherford classification), primary and secondary patency rates, TLR and TVR rates, and changes in ABI, the Walking Impairment Questionnaire, and the EQ-5D questionnaire from baseline.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania
- KEH Berlin
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Rendsburg, Alemania
- Imland Klinik Rendsburg
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Baden-Wurttemberg
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Bad Krozingen, Baden-Wurttemberg, Alemania, 79189
- Herzzentrum Bad Krozingen
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Rhineland-Palatinate
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Kaiserslautern, Rhineland-Palatinate, Alemania, 67657
- MVZ Kaiserslautern
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Saxony
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Leipzig, Saxony, Alemania, 04103
- Universitätsklinikum Leipzig
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Aalst, Bélgica
- Onze Lieve Vrouw Aalst
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Bonheiden, Bélgica
- Imelda Bonheiden
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Dendermonde, Bélgica
- Az Sint Blasius Dendermonde
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Genk, Bélgica
- ZOL Genk
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Barcelona, España
- Hospital Universitari Germans Trias i Pujol
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Barcelona, España
- Hospital de Santa Creu i Sant Pau
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Bilbao, España
- Hospital de Cruces
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Sabadell, España
- Hospital Parc Taulí
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Brest, Francia
- Centre Hospitalier Universitaire de Brest
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Paris, Francia
- Hôpital Paris Saint Joseph
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Paris, Francia
- CHU Pitié Salpêtrière
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Pessac, Francia
- Hôpital privé Saint-Martin
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Villeneuve-d'Ascq, Francia
- Hôpital privé Villeneuve d'Ascq
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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
Patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5). Patients with de novo atheromatous aorto-iliac lesions.
According to the incidence of TASC II lesions, approximately 70% of the patients will be classified as TASC II A or B lesions, while the other 30% will be classified as TASC II C or D lesions.
Descripción
Inclusion criteria
- ≥ 18 years of age
- Rutherford clinical stage 2 to 5
- Significant (≥70%) stenosis of atheromatous iliac lesions evidenced by duplex scan, MRI CT angiography or arteriography
- De novo atheromatous lesion of the aortoiliac segment
- Patient informed about the study and collection of the patient's informed consent agreement Exclusion criteria
Subjects will not be eligible to participate in the study if any of the following conditions are present in the subject:
- Protected adult patients, guardianship, curatorship, safeguard of justice
- Woman with possibility of pregnancy
- Patient with asymptomatic atheromatous lesions
- Patient with inflow lesion in the infrarenal aorta
- Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction)
- Acute ischemia or acute thrombosis
- Non-atherosclerotic disease
- History of coagulopathy
- Severe comorbidities with life expectancy <2 years
- Contraindication to taking antiplatelet aggregation therapy (aspirin or clopidogrel). The patient must be able to take an antiplatelet aggregation for at least 3 months after the procedure
- Patient participating in another clinical study which may interfere with the results
- Comorbidity or any reason which, according to the investigator, could limit the participation, the patient's adherence with the follow-up or the scientific integrity of the study
- Lesion near or adjacent to an aneurysm
- Inability to follow-up during the investigation
- Patient objection to participate in the investigation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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iCover covered stent
Percutaneous transluminal angioplasty (PTA) |
Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Primary Patency
Periodo de tiempo: 12 months after index procedure.
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The primary patency, defined as the absence of restenosis in the target lesion over the 12-month follow-up period in patients who did not undergo a reintervention on the target lesion. |
12 months after index procedure.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Technical success rate
Periodo de tiempo: Day 0.
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Technical success rate, defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30% after iCover stent graft insertion. Outcomes will be computed as the percentage of lesions treated at the end of the procedure. |
Day 0.
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Procedural success rate
Periodo de tiempo: Day 0.
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Procedural success rate, defined as technical success and no complications during the procedure including general and local complications as defined in the protocol. Outcomes will be computed as the percentage of patients at the end of the procedure. |
Day 0.
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Freedom from All Major Adverse Event (MAEs)
Periodo de tiempo: 1, 6, 12, 24 months after index procedure.
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MAEs are described as All-Cause Mortality post-procedure, Target Lesion Revascularization (TLR) post-procedure and Major Amputation of the Target Limb post-procedure (amputations above the ankle of the target leg). |
1, 6, 12, 24 months after index procedure.
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Incidence of Procedure- or Device- related Major Local Complications
Periodo de tiempo: Up to 30 days after index procedure.
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Incidence of Procedure- or Device- related Major Local Complications at the treated lesion or Puncture Site up to 30 days post-procedure. Major Local Complications include: Iliac arterial rupture, retroperitoneal hematoma, thrombosis of the iliac axis on the ipsilateral side, need for surgery to achieve hemostasis, bleeding with loss of more than 2 g/ dL of hemoglobin, false aneurysm at the puncture site, preventing resumption of walking at 24 hours or appearance of ischemia on the ipsilateral side. |
Up to 30 days after index procedure.
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Rates of Serious Adverse Events (SAEs)
Periodo de tiempo: 1, 6, 12, 24 months after index procedure.
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Rates of SAEs, including both related and unrelated events. SAEs will be categorized as related or unrelated to the procedure/device based on adjudication by an Independent Clinical Events Committee. |
1, 6, 12, 24 months after index procedure.
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Major amputation at target limb rate
Periodo de tiempo: 1, 6, 12, 24 months after index procedure.
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Percentage of patients with amputations above the ankle of the target leg will be counted. |
1, 6, 12, 24 months after index procedure.
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Primary sustained clinical improvement
Periodo de tiempo: 1, 6, 12, 24 months after index procedure.
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Primary sustained clinical improvement defined as a sustained upward shift of 1 category of the Rutherford classification for patients with claudication, and by wound healing and rest pain resolution for patients in critical limb ischemia, without the need for repeated target lesion revascularization in surviving patients. |
1, 6, 12, 24 months after index procedure.
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Primary patency rates
Periodo de tiempo: 6 and 24 months after index procedure.
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Primary patency rates, defined as the lack of restenosis without reintervention of the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, determined by either, duplex ultrasound examination considered as a peak systolic velocity index ≥ 2.4 at the target lesion, or by angio-CT (multiplanar reconstruction). In case of death, the vessel is considered as patent as long as no restenosis was detected during the last visit before the patient died. Outcomes will be computed as the percentage of lesions (Time frame: 6, 24 months after index procedure). |
6 and 24 months after index procedure.
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Secondary patency rates
Periodo de tiempo: 6, 12, 24 months after index procedure.
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Secondary patency rates, defined as the patency of the stent following an endovascular or surgical reintervention due to significant in-stent restenosis or occlusion. Outcomes computed as percentage of lesions. |
6, 12, 24 months after index procedure.
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Target lesion revascularization (TLR) rate
Periodo de tiempo: 1, 6, 12, 24 months after index procedure.
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Target lesion revascularization (TLR) rate, defined as the need for repeated procedures (endovascular or surgical) due to a problem arising from the lesion initially treated in surviving patients with preserved limbs. Outcomes will be computed as the percentage of lesions. |
1, 6, 12, 24 months after index procedure.
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Target vessel revascularization (TVR) rate
Periodo de tiempo: 1, 6, 12, 24 months after index procedure.
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Target vessel revascularization (TVR) rate, defined as the need for repeated procedures (endovascular or surgical) due to a problem arising remote from the vessel initially treated in surviving patients with preserved limbs. Outcomes will be computed as the percentage of lesions. |
1, 6, 12, 24 months after index procedure.
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Change in Ankle-Brachial Index (ABI) from baseline
Periodo de tiempo: 1, 6, 12, 24 months post-procedure.
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Change in ABI from baseline. |
1, 6, 12, 24 months post-procedure.
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Change in Walking Impairment Questionnaire from baseline
Periodo de tiempo: 1, 6, 12, 24 months post-procedure.
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The Walking Impairment Questionnaire values will be recorded and compared to the baseline values. This questionnaire is a validated tool to assess walking capability in patients with Peripheral Arterial Disease in different situations. |
1, 6, 12, 24 months post-procedure.
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Change in quality of life from baseline
Periodo de tiempo: 1, 6, 12, 24 months post-procedure.
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Change in quality of life from baseline, as measured by EQ-5D. The EQ-5D Questionnaire values will be recorded and compared to the baseline values. It is a validated questionnaire to measure the quality of life based on 5 different parameters. Worst possible score in this study would be 0, best possible score would be 1. In addition, the patient indicates her/his current health on an analog scale from 0 (worst) to 100 (best). |
1, 6, 12, 24 months post-procedure.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- iliCo Study
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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