Serrantor OCT Study

Not Applicable

Recruiting

• Conditions: Critical Limb Ischemia
• Interventions: Device: Serranator PTA Serration Catheter; Drug: PTA (Standard of Care)

• Registration Number: NCT06434194
• Lead Sponsor: Cagent Vascular LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Study Start: 2024-10-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serrantor	Serranator PTA Serration Catheter	Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon
PTA	PTA (Standard of Care)	Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.

Primary Outcome Measures

Name	Time	Method
Residual Lumen Volume Stenosis	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
OCT Residual Diameter Stenosis	Baseline	Residual stenosis as measured by OCT
Angiography Residual Diameter Stenosis	Baseline	Residual stenosis as measured by angiography
Dissection Pattern	Baseline	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.
Correlation of Luminal Gain and Plaque Modification	Baseline	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.
Rate of Optimal PTA	Baseline	Rate of procedures that achieve optimal PTA (\<30% diameter stenosis without flow-limiting dissection measured by angiography)
Bail-out Stenting	Baseline	Rate of bail-out stenting

Trial Locations

Locations (2)

Columbia University; 🇺🇸 New York, New York, United States

Weill Cornell Medical; 🇺🇸 New York, New York, United States