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Peripheral Bypass Trial for Completion Control

Description

The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle

Conditions

Chronic Limb-Threatening Ischemia
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Related Conditions:

Chronic Limb-Threatening Ischemia

Study Overview

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Study Details

Study overview

The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle

Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in Chronic Limb-Threatening Ischemia (CLTI) Patients

Peripheral Bypass Trial for Completion Control

Condition
Chronic Limb-Threatening Ischemia
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Chronic Limb-Threatening Ischemia as defined by presence of Peripheral Artery Disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration\>2 weeks duration (ref Global Guidelines)
  • * Atherosclerotic infra-popliteal PAD
  • * Adequate distal anastomotic target (crural, tibial or popliteal below the knee with one single run-off) between knee and ankle distal to the stenotic/occluded segment.
  • * Available autogenous vein conduit based on preoperative vein mapping.
  • * Understand the nature of the procedure and willingness to comply with protocol. Attend follow-up appointments and provide written informed consent.
  • * Bypass with artificial conduit or cryopreserved allografts
  • * Bypass for non-atherosclerotic lesions
  • * Life-expectancy less than 2 years
  • * Any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up.
  • * Any condition that the investigator believes should exclude participation.
  • * Excessive risk for adverse events during open surgery as judged by the investigator.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medistim ASA,

Study Record Dates

2027-12