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Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial Disease

NCT01834495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2019-08-14

No results posted yet for this study

Summary

The purpose of the investigators study is to examine and compare primary patency between balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus COMPLETE-SE) in atherosclerotic iliac artery lesion.

Conditions

Interventions

DEVICE

Balloon expandable stent

provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of \> 15mmHg, residual stenosis of \>30% and flow limiting dissection

DEVICE

Self expandable stent

provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of \> 15mmHg, residual stenosis of \>30% and flow limiting dissection

Sponsors & Collaborators

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Seung Woon Rha, MD. PhD · Cardiovascular center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-28
Primary Completion
2018-01-31
Completion
2019-02-11

Countries

  • South Korea

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 NCT01834495 on ClinicalTrials.gov