NCT01466634

Brief Summary

Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

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, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1 month

First QC Date

October 24, 2011

Last Update Submit

November 4, 2011

Conditions

Outcome Measures

Primary Outcomes (5)

  • late coronary lumen loss

    9 month

  • target lesion revascularization

    9 month

  • overall mortality

    1 year

  • Late stent thrombosis

    1 year

  • Myocardial Infarction

    1 year

Secondary Outcomes (1)

  • Binary restenosis

    9 months

Study Arms (2)

permanent polymer DES

Procedure: percutaneous coronary intervention with stent

bioabsorbable polymer DES

Procedure: percutaneous coronary intervention with stent

Interventions

patients with coronary artery disease treated by percutaneous coronary intervention with BP-DES are compared with patients with coronary artery disease treated by percutaneous coronary intervention with PP-DES

bioabsorbable polymer DESpermanent polymer DES

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with coronary artery disease with indication to percutaneous coronary intervention

You may qualify if:

  • randomized studies
  • studies reporting clinical outcomes as overall death and/or acute myocardial infarction and/or late stent thrombosis (ARC definition)\[\*\*\] and/or target lesion revascularization and/or late lumen loss
  • follow up period longer than 6 months.

You may not qualify if:

  • duplicate reporting (in which case the manuscript reporting the largest sample or the longest follow-up was selected)
  • inability to compute risk estimates due to absence of clinical event in one of the groups
  • studies presenting composite major adverse cardiac event (MACE) and not individual end points.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Maggiore della Carità

Novara, 28100, Italy

Location

Related Publications (1)

  • Lupi A, Rognoni A, Secco GG, Lazzero M, Nardi F, Fattori R, Bongo AS, Agostoni P, Sheiban I. Biodegradable versus durable polymer drug eluting stents in coronary artery disease: insights from a meta-analysis of 5,834 patients. Eur J Prev Cardiol. 2014 Apr;21(4):411-24. doi: 10.1177/2047487312467745. Epub 2012 Nov 14.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Percutaneous Coronary InterventionStents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresProstheses and ImplantsEquipment and Supplies

Study Officials

  • Alessandro Lupi, MD

    AOU Maggiore della Carita

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 24, 2011

First Posted

November 8, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations