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Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe

NCT01661231 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2017-02-03

No results posted yet for this study

Summary

BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE. The objective of this study is to separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents in the European arm of the BIOFLEX-I IDE (NCT01319812). The Pulsar-18 stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.

Conditions

Interventions

DEVICE

Astron/Pulsar-18 stent

Peripheral Vascular Intervention

Sponsors & Collaborators

  • Biotronik, Inc.

    collaborator INDUSTRY

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Marianne Brodmann, MD · Medical University of Graz, Graz, Austria

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-09-30
Completion
2018-10-31

Countries

  • Austria
  • Belgium
  • Germany
  • Switzerland

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 NCT01661231 on ClinicalTrials.gov