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)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Rutherford clinical category 4-6 of the target limb
• Age of subjects is \>18 years old
• Patients has given informed consent to participate in this study
Locations
United States
New York
Columbia University
RECRUITING
New York
Weill Cornell Medical
RECRUITING
New York
Contact Information
Primary
Feeny
kjclinconsulting@gmail.com
4197878496
Backup
Wittwer
twittwer@mededge.io
Time Frame
Start Date: 2024-10-31
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 60
Treatments
Active_comparator: Serrantor
Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon
Active_comparator: PTA
Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.
Related Therapeutic Areas
Sponsors
Leads: Cagent Vascular LLC