RECRUITING

Peripheral Bypass Trial for Completion Control

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Conditions

Chronic Limb-Threatening IschemiaCLTI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-09
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06264843

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Atherosclerotic infra-popliteal PAD
  3. * 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.
  4. * Available autogenous vein conduit based on preoperative vein mapping.
  5. * Understand the nature of the procedure and willingness to comply with protocol. Attend follow-up appointments and provide written informed consent.
  1. * Bypass with artificial conduit or cryopreserved allografts
  2. * Bypass for non-atherosclerotic lesions
  3. * Life-expectancy less than 2 years
  4. * Any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up.
  5. * Any condition that the investigator believes should exclude participation.
  6. * Excessive risk for adverse events during open surgery as judged by the investigator.

Contacts and Locations

Study Contact

Anne Waaler
CONTACT
+4790892713
anne.waaler@medistim.com

Study Locations (Sites)

University of California
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Medistim ASA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-09
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • CLTI

Additional Relevant MeSH Terms

  • Chronic Limb-Threatening Ischemia