Recruiting

Serrantor

Sponsor:

Cagent Vascular LLC

Code:

NCT06434194

Conditions

Critical Limb Ischemia

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Serranator PTA Serration Catheter

PTA (Standard of Care)

Study Details

Brief summary:

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

Conditions

Critical Limb Ischemia

Study ID

NCT06434194

Start date

Oct 31, 2024

Status verified date

May, 2025

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Serrantor

Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon

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.

Interventions

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.

PTA (Standard of Care)

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

Primary outcome measure

  • Residual Lumen Volume Stenosis [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Feeny

4197878496kjclinconsulting@gmail.com

Wittwer

twittwer@mededge.io

Locations

Columbia University

Recruiting

New York, New York, United States, 10032

Weill Cornell Medical

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

Cagent Vascular LLC

Last update posted

May 18, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cagent Vascular LLC on 2025-05-18.