Health TrialsbyHealthPanel

Serrantor OCT Study

ConditionCritical Limb Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorCagent Vascular LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serranator PTA Serration Catheter

    Device

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SerrantorActive comparator 1 intervention
Group B: PTAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

OCT Residual Diameter Stenosis

Residual stenosis as measured by OCT

Time frame
Baseline
2

Angiography Residual Diameter Stenosis

Residual stenosis as measured by angiography

Time frame
Baseline
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cagent Vascular LLC

Lead sponsor

Source ClinicalTrials.gov
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