RECRUITING

Serranator POINT FORCE Registry

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 objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario. The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.

Official Title

POst-Market ClINical Follow-up STudy of the SerranatOR PTA Serration Balloon CathEter

Quick Facts

Study Start:2025-01-22
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06687590

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. * Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.
  2. * Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.
  3. * Age of subject is \> 18.
  4. * Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.
  1. * Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.
  2. * Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Contacts and Locations

Study Contact

Alexis Shewfelt
CONTACT
6502086743
ashewfelt33@cagentvascular.com

Study Locations (Sites)

UT Southwestern
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Cagent Vascular LLC

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 Date2025-01-22
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-01-22
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Artery Disease (PAD)
  • Dysfunctional AV Fistula
  • Dysfunctional AV Graft