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Serranator Recoil Study

NCT05161039 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-09

No results posted yet for this study

Summary

The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.

Conditions

  • Peripheral Arterial Disease
  • Critical Limb Ischemia

Interventions

DEVICE

Serranator

Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular

DEVICE

POBA

Plain balloon angioplasty device

Sponsors & Collaborators

  • Cagent Vascular LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161039 on ClinicalTrials.gov