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Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries

NCT02013193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2019-12-23

No results posted yet for this study

Summary

The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.

Conditions

Interventions

DEVICE

Ranger DCB

After successful pre-dilatation the index lesion is treated with one or two Ranger DCB devices that completely cover the lesion. If two devices are deployed, overlap shall be minimal.

DEVICE

uncoated PTA balloon

The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.

Sponsors & Collaborators

  • CERES GmbH

    collaborator INDUSTRY

  • coreLab Black Forest GmbH

    collaborator UNKNOWN

  • Hemoteq AG

    lead INDUSTRY

Principal Investigators

  • Dierk Scheinert, M.D. · University Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-07
Primary Completion
2016-06-16
Completion
2019-03-15

Countries

  • Austria
  • France
  • Germany

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 NCT02013193 on ClinicalTrials.gov