Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

Официальное название

Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.

Обзор

VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula

Подробное описание

Structure

This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:

* Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula

Duration The primary endpoint is defined at 6 month post index procedure of fistula creation. Patients will be further followed up to 12 months post index procedure.

Main study question What is the magnitude of benefit of the VasQ device with regard to time to achieving a clinically functional AVF as compared to a comparable contemporary standard of care cohort?

Вмешательства

• Устройство VasQ
  External support implant for the arteriovenous fistula
• Процедура Arteriovenous fistula creation for dialysis vascular access
  End to side fistula creation in the arm for dialysis vascular access

Первичные конечные точки

• Fistula functional success [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.
• Male and non-pregnant female participants.
• Age 18-80 years
• Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.

Критерии исключения

• Index procedure being a revision surgery of an existing fistula.
• Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)
• Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
• Known central venous stenosis or obstruction on the side of surgery.
• Pre-existing stents or stent grafts in the access circuit.
• Planned subsequent fistula superficialization procedure.
• Known coagulation disorder.
• Known allergy to nitinol.
• Expected kidney transplant within 12 months of enrollment.
• Inability to give consent and/or comply with the study follow up schedule.
• Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).
• Participation in another interventional study that in the judgment of the investigator could confound study results.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 9 центров

• Fresenius Vascular Care Long Beach — Long Beach
• Sarasota Memorial Hospital — Sarasota
• Grady Memorial Hospital — Atlanta
• Brigham and Women's Hospital — Boston
• Greenwood Leflore Hospital — Greenwood
• Azura Surgery Center Las Vegas — Las Vegas
• Fresenius Vascular Care Columbia — Columbia
• Houston Methodist Hospital — Houston
• … и ещё 1 центр

Идентификаторы

NCT: NCT06516653 · CD0261

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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