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Drug Eluting Balloon Versus Drug Eluting Stent in PCI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT01760200
First received: December 16, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

Drug eluting balloons (DEB) have been developed to overcome the limitations of drug eluting stent (DES), but clinical results of different studies about DEB are not consistent.

Thus, we planned a meta-analysis to compare outcomes of DEB and DES in coronary artery disease (CAD).


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Drug Eluting Balloon Versus Drug Eluting Stent in Coronary Artery Disease PCI: Insights From a Meta-analysis of 1462 Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • Overall mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    mortality rate from all cause


Secondary Outcome Measures:
  • Myocardial infarction rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Myocardial infarction rates

  • Target vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    symptoms or ischemia driven new revascularization of the coronary artery already treated with DEB at baseline


Enrollment: 1462
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Drug eluting balloon angioplasty
Drug eluting balloon angioplasty
Drug eluting stent group
Drug eluting stent intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with CAD treated by coronary angiogrphy

Criteria

Inclusion Criteria:

  • randomized studies or cohort studies reporting a comparison between a DEB treated group and a DES treated group
  • availability of reports of late lumen loss (LLL) and/or overall death and/or myocardial infarction (MI) and/or stent thrombosis (ST) and/or target lesion revascularization (TLR).

Exclusion Criteria:

  • duplicate reporting (in which case the manuscript reporting the largest sample or the longest follow-up was selected)
  • follow up of at least 1 year
  • studies presenting composite major adverse cardiac events (MACE) without mentioning individual end points.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760200

Locations
Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, Piedmont, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Principal Investigator: Alessandro Lupi, MD AO Maggiore della Carita
  More Information

No publications provided

Responsible Party: Lupi Alessandro, M.D., Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01760200     History of Changes
Other Study ID Numbers: 0000003
Study First Received: December 16, 2012
Last Updated: January 2, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
Coronary angioplasty
Coronary stent
paclitaxel drug-eluting stent
drug eluting balloon

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013