Serrantor OCT Study

Cagent Vascular LLC60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Critical Limb Ischemia

Interventions

Serranator PTA Serration CatheterDEVICE

The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.

PTA (Standard of Care)DRUG

A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

Columbia University

New York, New York, United States

RECRUITING

Weill Cornell Medical

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

OCT Residual Diameter Stenosis

Residual stenosis as measured by OCT

Time frame: Baseline

Angiography Residual Diameter Stenosis

Residual stenosis as measured by angiography

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Rate of Optimal PTA

Rate of procedures that achieve optimal PTA (\<30% diameter stenosis without flow-limiting dissection measured by angiography)

Time frame: Baseline

Bail-out Stenting

Rate of bail-out stenting

Central Contacts

Feeny

CONTACT

4197878496 kjclinconsulting@gmail.com

Wittwer

CONTACT

twittwer@mededge.io

Data from ClinicalTrials.gov

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