Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies

Обзор

The study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft. Clinical utility measures throughout the procedure and until discharge will be assessed

Подробное описание

Prospective, single-arm, non-randomised, multicenter, investigator initiated clinical study evaluating subjects implanted with The Valiant Captivia physician fenestrated stent graft for the treatment of aneurysms/penetrating ulcers, Type B aortic dissections or residual dissection after Type A repair, of the aortic arch and the descending thoracic aorta which are candidates for revascularisation of all three supra-aortic vessels (BT (brachiocephalic trunk) , LCCA (left Common Carotid artery), LSA (Left Subclavian Artery)

Вмешательства

• Устройство The Valiant Captivia Stent Graft
  Aortic arch/Descending aorta Repair

Первичные конечные точки

• Primary Safety Endpoints: [Срок оценки: 30 days]
• Primary Effectiveness Endpoints: [Срок оценки: 30 days]

Вторичные конечные точки (12)

• Intra/periprocedural through Discharge Clinical Utility Measures 1 [Срок оценки: 0 to 30 days]
• Intra/periprocedural through Discharge Clinical Utility Measures 2 [Срок оценки: 0 to 30 days]
• Intra/periprocedural through Discharge Clinical Utility Measures 3 [Срок оценки: 0 to 30 days]
• Intra/periprocedural through Discharge Clinical Utility Measures 4 [Срок оценки: 0 to 30 days]
• Intra/periprocedural through Discharge Clinical Utility Measures 5 [Срок оценки: 0 to 30 days]
• Intra/periprocedural through Discharge Clinical Utility Measures 6 [Срок оценки: 0 to 30 days]
• Intra/periprocedural through Discharge Clinical Utility Measures 7 [Срок оценки: 0 to 30 days]
• Major adverse event [Срок оценки: Up to 3 years]
• Secondary endovascular procedures [Срок оценки: Up to 3 years]
• Secondary endovascular procedures for primary device failures [Срок оценки: Up to 3 years]
• Other [Срок оценки: Up to 3 years]
• For TBAD, these additional observations will be evaluated [Срок оценки: 0 to 30 days]

Критерии участия

Критерии включения

TAA/PAU (Thoracic Aortic Aneurysms and Penetrating Ulcers):

• Subject is at least 18 years of age.
• Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
• Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.
• Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.
• Subject has a TAA/PAU which is:

• a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR
• a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm in diameter, or symptomatic)
• Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm
• Subject has no thrombus in the proximal neck
• Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter of the ascending aorta is ≤ 40 mm
• Subject has a non-diseased LSA which is eligible for stent-grafting
• Subject has sufficient landing zone within the LSA to accommodate the stent-graft without occlusion of any significant vessels
• Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories.
• Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft
• Subject is affiliated with the social security system

Критерии включения

TBAD(Type B Dissections) and Residual dissection after Type A repair:

• Subject is at least 18 years of age.
• Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
• a) Subject has a degenerative aortic arch aneurysm which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And/or b) Subject has a complicated TBAD (acute, subacute or chronic) which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And/or c) Subject has a complicated residual dissection after replacement of the ascending aorta for type A aortic dissection which will require coverage of the LSA and extension of the proximal seal zone to zone 0
• Subject has a healthy, non-diseased (without thrombus) aortic proximal seal zone of at least 20 mm
• Subject has a healthy, non-diseased (without thrombus) aortic distal seal zone of at least 20 mm
• Subject has a maximum diameter of the distal ascending aorta just above the BT of 40 mm
• Subject has a non-diseased aortic diameter between 28 mm to 42 mm and the ascending aorta ≤ 40 m
• Subject has a no atheromatous lesions int the arch and the BT, LCCA and LSA
• Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories
• Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft
• Subject is affiliated with the social security system

Критерии исключения

(Thoracic Aortic Aneurysms and Penetrating Ulcers, TAA/PAU):

• Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
• Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
• Subject has an aneurysmal, tortuous, or atherosclerotic BT.
• Subject has an ascending aorta diameter > 40 mm
• Subject has thrombus in the proximal neck
• Subject has an emergent need of treatment of the aortic pathology
• Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites
• Subject has circumferential calcification in the common femoral or external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
• Subject has an aortic atheroma classified as grade IV or grade V.
• Subject has had previous endovascular repair of the ascending
• Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise sealing of the device.
• Subject is pregnant
• Subject has a known allergy or intolerance to the device components.
• Subject is in acute renal failure
• Subject has a body habitus which prevents adequate visualisation of the aorta.
• Subject has coronary artery disease with unstable angina and who has not received treatment.
• Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
• Subject has active systemic infection and/or a mycotic aneurysm.
• Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observations of this study.
• Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
• Subject has a life expectancy of less than 2 years year.
• Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
• Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm <30 days of implantation of investigational device.
• Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
• Subject has had a cerebral vascular accident (CVA) within 3 months.
• Subject has had a myocardial infarction (MI) within 3 months.
• Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

Критерии исключения

(Type B Dissections, TBAD and residual dissection after Type A repair):

• Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
• Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
• Subject has an aneurysmal, tortuous, or atherosclerotic BT.
• Subject has a dissected BT and or LCCA
• Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites.
• Subject has circumferential calcification in the common femoral artery, external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
• Subject has an aortic atheroma classified as grade IV or grade V.
• Subject has had previous endovascular repair of the ascending, arch
• Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal sealing sites that would compromise seal of the device
• Subject is pregnant
• Subject has a known allergy or intolerance to the device components
• Subject is in acute renal failure
• Subject has a body habitus which prevents adequate visualisation of the aorta.
• Subject has coronary artery disease with unstable angina and who has not received treatment.
• Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
• Subject has active systemic infection and/or a mycotic aneurysm.
• Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observationsof this study
• Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
• Subject has a life expectancy of less than 2 years.
• Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
• Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm <30 days of implantation of investigational device.
• Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
• Subject has had a cerebral vascular accident (CVA) within 3 months.
• Subject has had a myocardial infarction (MI) within 3 months.
• Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 4 центра

• CH de Brest — Brest
• Hôpital Louis Pradel — Bron
• CHU de Montpellier — Montpellier
• CH d'Orléans — Orléans

Идентификаторы

NCT: NCT05479305 · EVERGREEN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗