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Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents

NCT01319812 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2019-03-21

Study results available
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Summary

The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar 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 Stents

Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery.

DEVICE

Pulsar Stents

Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries.

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Burket, MD · University of Toledo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-09-30
Completion
2017-09-07

Countries

  • United States
  • Canada

Study Locations

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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 NCT01319812 on ClinicalTrials.gov