Serrantor OCT Study

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)

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

Study Overview

• Status: Recruiting
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Device: Serranator PTA Serration Catheter; Drug: PTA (Standard of Care)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feeny; Phone Number: 4197878496; Email: kjclinconsulting@gmail.com
• Study Contact Backup: Name: Wittwer; Email: twittwer@mededge.io

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
      • Contact: K Dalton
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical
      • Contact: R Chu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
• Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
• Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
• Lesion length less than 220 mm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Serrantor; Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon	Device: Serranator PTA Serration Catheter; The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
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.	Drug: PTA (Standard of Care); A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Lumen Volume Stenosis	Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OCT Residual Diameter Stenosis	Residual stenosis as measured by OCT	Baseline
Angiography Residual Diameter Stenosis	Residual stenosis as measured by angiography	Baseline
Dissection Pattern	The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration.	Baseline
Correlation of Luminal Gain and Plaque Modification	The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab.	Baseline
Rate of Optimal PTA	Rate of procedures that achieve optimal PTA (<30% diameter stenosis without flow-limiting dissection measured by angiography)	Baseline
Bail-out Stenting	Rate of bail-out stenting	Baseline

Collaborators and Investigators

• Sponsor: Cagent Vascular LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: CSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes