xDot Access Management System Early Feasibility Study

Официальное название

xDot Access Management System Early Feasibility Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites

Обзор

The objective of this study is to demonstrate safety and investigate effectiveness of the xDot Access Management System (AMS) for closure of large bore femoral-arterial and femoral-venous access sites.

Подробное описание

The investigation is a prospective, multi-center, single-arm early feasibility study composed of two (2) distinct cohorts: femoral-arterial and femoral-venous. The purpose of this study is to demonstrate the safety and assess the effectiveness of the xDot AMS for closing the access sites of the femoral artery (femoral-arterial cohort) and femoral vein (femoral-venous cohort). This is a treatment-only early feasibility study (EFS) intended to capture and characterize outcomes, especially safety outcomes, with the xDot AMS.

Вмешательства

• Устройство xDot Access Management System (AMS)
  The xDot AMS is designed to deliver the xDot Implant Unit in the anterior wall of the target vessel to close the puncture site.

Первичные конечные точки

• Freedom from major complications of the target access site [Срок оценки: 30 days post-procedure]
• Time to hemostasis (TTH) [Срок оценки: During procedure]

Критерии участия

Критерии включения

• Age 18 to 80 years
• Willing and able to provide written informed consent prior to initiation of study procedures
• Willing and able to comply with the protocol-specified procedures and assessments
• Investigator opinion suitable for xDot AMS for femoral closure (arterial or venous, as applicable)
• Minimum vessel diameter of 5.5 mm and vessel depth ≥1.5 cm and ≤5.0 cm, <50% stenosis for the: a. femoral artery, as determined by computed tomography angiography (CTA) b. femoral vein, as determined by duplex ultrasound (DUS) or angiogram.
• Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure through:

• The common femoral artery using 8F to 22F devices or sheaths (max 26F OD; e.g., TAVR, EVAR)
• The common femoral vein using 8F to 26F devices or sheaths (max 30F OD; e.g., transcatheter mitral/tricuspid valve repair/replacement and LAA occlusion)

Критерии исключения

• Individuals who are pregnant, planning to become pregnant, or lactating
• Immunocompromised or with pre-existing autoimmune disease
• Active systemic infection or a local infection at or near the access site
• Known or suspected COVID-19 infection
• Significant anemia (hemoglobin <10 g/dL, hematocrit <30%)
• Morbidly obese or cachectic (Body mass index \[BMI\] >40 kg/m2 or <20 kg/m2)
• Severe co-existing co-morbidities which, in the opinion of the investigator, would clinically confound the study primary endpoints
• Known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
• Allergy to any device material, including polypropylene, NiTinol, or Titanium
• Common femoral artery or vein with calcium, as determined by baseline CTA or angiogram, which, in the clinical judgment of the investigator, precludes safe access, or severe peripheral vascular disease as evidenced by severe claudication when ambulating <100 feet, weak or absent pulses in the affected limb, or ankle-brachial index (ABI) <0.5 at rest
• Previous iliofemoral intervention in the region of the access site, including prior atherectomy, stenting, or surgical or grafting procedures
• Use of an intra-aortic balloon pump through the access site within 30 days prior to the baseline evaluation
• Continuous oral anticoagulation therapy that cannot be stopped for the peri-procedural period or international normalized ratio (INR) >1.8 at the time of the procedure
• Unable to be adequately anti-coagulated for the procedure
• Unable to ambulate at baseline (e.g., wheelchair user or confined to bed)
• ST-elevation myocardial infarction (MI) within 30 days prior to procedure or acute coronary syndrome (i.e., unstable angina or MI) ≤30 days before the catheterization procedure
• New York Heart Association (NYHA) class IV heart failure
• Left ventricular ejection fraction <20%
• Unilateral or bilateral lower extremity amputation
• Renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy
• Existing nerve damage in the ipsilateral leg
• Additional planned endovascular procedure within the next 30 days
• Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period
• Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

Intraprocedural Exclusion Criteria

Patients will be excluded from participating in this trial if any of the following exclusion criteria occur at the time of the procedure, prior to introduction of the xDot AMS into the patient:

• Hypertension with blood pressure (BP) ≥180/110 mm Hg at the initial time of the procedure that cannot adequately be controlled.
• Presence of the following at the target access site (arterial or venous): i) hematoma, ii) AV fistula, iii) pseudoaneurysm, or iv) thrombus
• Puncture site scenarios for the femoral artery or vein:

• Sites in target groin within the prior 14 days
• Sites in the target that have not healed
• Puncture is through the posterior wall or if there are multiple punctures in the same access site
• Access site above the most inferior border of the inferior epigastric artery/vein and/or above the inguinal ligament based upon bony landmarks
• Access site is below the femoral artery/vein bifurcation

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

США · 3 центра

• CentraCare Heart and Vascular Center — Saint Cloud
• Oklahoma Heart Institute — Tulsa
• North Central Heart — Sioux Falls

Идентификаторы

NCT: NCT07464353 · xDOT-CL-5000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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