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NCT Number: NCT06434194

Serrantor OCT Study

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

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Residual Lumen Volume Stenosis

    Time frame: 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 outcomes

  1. OCT Residual Diameter Stenosis

    Time frame: Baseline

    Residual stenosis as measured by OCT

  2. Angiography Residual Diameter Stenosis

    Time frame: Baseline

    Residual stenosis as measured by angiography

  3. Dissection Pattern

    Time frame: 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.

  4. Correlation of Luminal Gain and Plaque Modification

    Time frame: 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.

  5. Rate of Optimal PTA

    Time frame: Baseline

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

  6. Bail-out Stenting

    Time frame: Baseline

    Rate of bail-out stenting

Study contacts

Contact information is provided by the study sponsor or research team.

Feeny

CONTACT

[email protected]

4197878496

Wittwer

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cagent Vascular LLC

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 30, 2024
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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