Идёт набор NCT06951685

Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study

Без фазы С лечением Peripheral Artery Occlusive Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.
Кому может быть актуально: Состояния в реестре: Peripheral Artery Occlusive Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Costa Rica
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit

Обзор

A prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective above-knee femoral popliteal bypass surgery.

Вмешательства

Устройство Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
The XPAD bypass conduit is a sterile, restorative biodegradable polymer-based vascular graft, consisting of a tubular structure with a 33cm length and 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The XPAD conduit is in a straight configuration and may be implanted above the knee for elective femoral popliteal bypass surgery.

Первичные конечные точки

Primary patency rate [Срок оценки: 12 months]
Freedom from device-related SAE [Срок оценки: Day 1, 1, 6 and 12 months]

Вторичные конечные точки (7)

Implantation success rate [Срок оценки: Day 1]
Freedom from Major Bleeding events [Срок оценки: Day 1, 1 and 6 months]
Patency (primary, primary assisted, and secondary) rates [Срок оценки: 6, 12, 24, and 36 months]
Freedom from device-related SAE [Срок оценки: 24 and 36 months]
Rate of wound/graft infections [Срок оценки: 1, 6, 12, 24, and 36 months]
Freedom from Major Amputations [Срок оценки: 1, 6, 12, 24, and 36 months]
Freedom from all-cause mortality [Срок оценки: 1, 6, 12, 24, and 36 months]

Критерии участия

Критерии включения

Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery
Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease and TASC C or D lesions. Rutherford grade 5 may be included with a wound, ischemia and foot infection (WiFi) classification of up to grade 2, provided there are two outflow vessels with at least one reaching the pedal arch
At least 18 years of age at screening
Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography
Life expectancy of at least 24 months

Критерии исключения

Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
Presence or history of bypass in the diseased limb
Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts
Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
History of acute arterial occlusion requiring an emergent intervention
Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
Previous renal transplant
Uncontrolled arterial hypertension (BP >200 mmHg) at 2 successive readings
Uncontrolled or poorly controlled diabetes
Abnormal blood values that could influence patient recovery and or/ graft hemostasis
Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18 seconds
Any active local or systemic infection
Known heparin-induced thrombocytopenia
Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
Previous enrolment in this study
Subject is participating in another study
Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit