RECRUITING

Serrantor OCT Study

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

TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.

Official Title

Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)

Quick Facts

Study Start:2024-10-31
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06434194

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:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Rutherford clinical category 4-6 of the target limb
  2. * Age of subjects is \>18 years old
  3. * Patients has given informed consent to participate in this study
  1. * De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
  2. * Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
  3. * Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
  4. * Lesion length less than 220 mm

Contacts and Locations

Study Contact

Feeny
CONTACT
4197878496
kjclinconsulting@gmail.com
Wittwer
CONTACT
twittwer@mededge.io

Study Locations (Sites)

Columbia University
New York, New York, 10032
United States
Weill Cornell Medical
New York, New York, 10065
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 Date2024-10-31
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2024-10-31
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Critical Limb Ischemia