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NCT02228564 · ClinicalTrials.gov registry record · NA

BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease

A NA study of Peripheral Artery Disease and Peripheral Vascular Disease, sponsored by C. R. Bard.

Completed
Registry status
NA
Development phase
155
Enrollment target
20
Study locations

NCT02228564: Completed NA study of Peripheral Artery Disease and Peripheral Vascular Disease, sponsored by C. R. Bard.

NCT02228564 is a NA study of Peripheral Artery Disease and Peripheral Vascular Disease that has completed, run by C. R. Bard. The registered enrollment target is 155 participants, above the 124-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02228564, a NA study of Peripheral Artery Disease and Peripheral Vascular Disease, has completed, sponsored by C. R. Bard.

COMPLETED
Registry status
NA
Development phase
155 participants
Enrollment target
20
Study locations

Study Summary

Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.

Primary Outcome

The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.

Interventions

  • PROCEDURE Percutaneous transluminal angioplasty (PTA)
  • DEVICE LIFESTREAM™ covered stent

Study Locations (20)

Other

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH - Bad Krozingen
  • Ev.Krankenhaus Königin Elisabeth - Berlin
  • Praxis fur Interventionelle Angiologie - Kaiserslautern
  • Universitaetsklinikum Leipzig - Leipzig
  • Bonifatius Hospital - Lingen
  • Auckland Hospital - Auckland

Florida

  • Florida Research Network - Gainesville
  • Baptist Medical Center - Jacksonville
  • Lakeland Regional Medical Center - Lakeland
  • Mount Sinai Medical Center - Miami

California

  • Vascular and Interventional Specialists of Orange County - Orange
  • UC Davis Cardiovascular Medicine - Sacramento

North Carolina

  • CaroMont Regional Medical Center - Gastonia
  • North Carolina Heart and Vascular - Raleigh

Arkansas

  • Arkansas Heart Hospital - Little Rock

Massachusetts

  • University of Massachusetts Worcester - Worcester

Missouri

  • Kansas City Vascular Foundation - Kansas City

Pennsylvania

  • Donald Guthrie Foundation - Sayre

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2014-09
Est. Completion 2018-12
Phase NA
C. R. Bard

75 total trials

What the finished NCT02228564 record still lists

NCT02228564 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 124-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (25% higher).

The record links to 3 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Percutaneous transluminal angioplasty (PTA) is the first listed.

NCT02228564 names 20 study sites across 10 states, led by Other, Florida, California.

Frequently Asked Questions

What is clinical trial NCT02228564 about?

NCT02228564 is a clinical study titled "BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease". Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.

What is the current status of trial NCT02228564?

This trial is currently completed. It is a NA study. The enrollment target is 155 participants. The study started on 2014-09. Estimated completion is 2018-12.

What conditions does trial NCT02228564 study?

This clinical trial studies the following conditions: Peripheral Artery Disease, Peripheral Vascular Disease, Arterial Occlusive Disease.

What interventions are being tested in trial NCT02228564?

The interventions under investigation include: Percutaneous transluminal angioplasty (PTA) (PROCEDURE), LIFESTREAM™ covered stent (DEVICE).

Who is sponsoring clinical trial NCT02228564?

This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02228564 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Peripheral Artery Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02228564's enrollment target sits among peer trials

155 18th of 50 higher than 32 of 50 other Peripheral Artery Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Peripheral Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02228564, the US trial registry maintained by the National Library of Medicine. NCT02228564 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.