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Prospective Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral And/or Popliteal Arteries Using the FLEX Scoring Catheter Plus DCB

NCT03676842 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-11-26

No results posted yet for this study

Summary

Prospective, single-center, single-arm, non-randomized study to assess the safety and efficacy of the FLEX Scoring Catheter in patients with atherosclerotic peripheral artery disease in the superficial femoral and popliteal arteries.

Conditions

Interventions

COMBINATION_PRODUCT

FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB

Treatment by the FLEX Scoring Catheter followed by an IN.PACT Admiral DCB

Sponsors & Collaborators

  • VentureMed Group Inc.

    lead INDUSTRY

Principal Investigators

  • Louis Lopez, MD · Allen County Cardiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2020-09-23
Completion
2020-09-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03676842 on ClinicalTrials.gov