MedTrace Logo

Drug-eluting Balloon in Acute Myocardial Infarction

NCT00856765 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-05-02

No results posted yet for this study

Summary

The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without impairing the process of normal vascular healing and endothelial function.

The goals of this study are:

1. To compare 6-month angiographic outcome after primary angioplasty using drug eluting balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.
2. To compare stent apposition and stent endothelialization after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
3. To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.

Conditions

Interventions

DEVICE

Drug eluting balloon

Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel

DEVICE

Bare metal stent

Bare metal stent

DEVICE

Drug eluting stent

Paclitaxel eluting stent

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Pieter Stella, MD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-06-30
Completion
2016-11-30

Countries

  • Italy
  • Netherlands

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 NCT00856765 on ClinicalTrials.gov