CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 155 enrolled
Drug / intervention
Percutaneous transluminal angioplasty (PTA) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02228564
NCT02228564N/ACompleted
CompareCT.gov

A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)

C. R. Bard·interventional·Posted Aug 29, 2014·Updated Oct 8, 2020

In Brief

A clinical study evaluating Percutaneous transluminal angioplasty (PTA) and LIFESTREAM™ covered stent for Peripheral Artery Disease and 2 related conditions. Completed, enrolled 155 participants across 20 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease, Peripheral Vascular Disease, Arterial Occlusive Disease
CountriesGermany, New Zealand, United States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 29, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2016
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.8 years ago

Interventions

Percutaneous transluminal angioplasty (PTA)procedure

Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

LIFESTREAM™ covered stentdevice

Implantation of the LIFESTREAM™ covered stent