NCT01760200

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

December 16, 2012

Last Update Submit

January 2, 2013

Conditions

Coronary Artery Disease

Keywords

Coronary angioplastyCoronary stentpaclitaxel drug-eluting stentdrug eluting balloon

Outcome Measures

Primary Outcomes (1)

  • Overall mortality

    mortality rate from all cause

    1 year

Secondary Outcomes (2)

  • Myocardial infarction rates

    1 year

  • Target vessel revascularization

    1 year

Study Arms (2)

Drug eluting balloon angioplasty

Drug eluting balloon angioplasty

Drug eluting stent group

Drug eluting stent intervention

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with CAD treated by coronary angiogrphy

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, Piedmont, 28100, Italy

Location

Related Publications (1)

  • Lupi A, Rognoni A, Secco GG, Porto I, Nardi F, Lazzero M, Rossi L, Parisi R, Fattori R, Genoni G, Rosso R, Stella PR, Sheiban I, Bolognese L, Liistro F, Bongo AS, Agostoni P. Drug eluting balloon versus drug eluting stent in percutaneous coronary interventions: insights from a meta-analysis of 1462 patients. Int J Cardiol. 2013 Oct 12;168(5):4608-16. doi: 10.1016/j.ijcard.2013.07.161. Epub 2013 Jul 26.

    PMID: 23948110DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Alessandro Lupi, MD

    AO Maggiore della Carita

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 16, 2012

First Posted

January 4, 2013

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

IT(1)