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Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.

NCT02939924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-23

No results posted yet for this study

Summary

Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.

Conditions

Interventions

DEVICE

Kanshas DCB

The appropriate Kanshas DCB size is selected after review of the patient's baseline angiogram and determination of the reference vessel diameter and lesion length. The balloons is sized to ensure the full length of the lesion is treated. The initial inflation of the study device should be approximately 1 minute for optimal drug release. In order to optimize lesion dilatation, longer inflation times are possible at the discretion of the operator.

Sponsors & Collaborators

  • Terumo Europe N.V.

    lead INDUSTRY

Principal Investigators

  • Michael Lichtenberg, MD · Karolinen-Hospital Klinikum Arnsberg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-07
Primary Completion
2018-07-18
Completion
2023-03-29

Countries

  • Belgium
  • 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 NCT02939924 on ClinicalTrials.gov