MedTrace Logo

Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

NCT02561299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-07-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.

Conditions

  • PAD
  • Vascular Calcification

Interventions

DEVICE

Peripheral Orbital Atherectomy System

Orbital Atherectomy

DEVICE

014 Drug Coated Balloon

Drug Coated Balloon

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Professor Marianne Brodmann, Dr. · Medical University of Graz, Austria

  • Professor Gunnar Tepe, Dr. · Klinikum Rosenheim Germany

  • Professor Thomas Zeller, Dr. · Herz-Zentrum Bad Krozingen Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-07-02
Completion
2019-07-02

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

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 NCT02561299 on ClinicalTrials.gov