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Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions

NCT03332264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2024-02-15

No results posted yet for this study

Summary

Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.

Conditions

  • Stenosis
  • Occlusion
  • Restenosis

Interventions

DEVICE

SeQuent Please OTW

Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter

DEVICE

Eluvia Vascular Stent System

Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent

DEVICE

Nitinol stent

Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • InnoRa GmbH

    lead INDUSTRY

Principal Investigators

  • Gunnar Tepe, MD · RoMed Klinikum Rosenheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2022-01-31
Completion
2023-12-12

Countries

  • Austria
  • 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 NCT03332264 on ClinicalTrials.gov