A Multicenter Registry of Consecutive Patients Undergoing Cardiac and Noncardiac Surgery or Operative Endoscopic/Endovascular Procedures After Implantation of a Coronary Stent

Azienda USL Reggio Emilia - IRCCS1 site in 1 country40 target enrollmentJune 10, 2013

ConditionsPERCUTANEOUS CORONARY INTERVENTION STENTS SURGERY

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: PERCUTANEOUS CORONARY INTERVENTION
Sponsor: Azienda USL Reggio Emilia - IRCCS
Enrollment: 40
Locations: 1
Primary Endpoint: The composite of death, myocardial infarction, probable/definite stent thrombosis according the Academic Research Consortium definition and bleeding events of Bleeding Academic Research Consortium (BARC)grade >3 during index surgical admission.
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The SAS registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. The relevant clinical, procedural and outcome data (within index surgical admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF).

Registry

clinicaltrials.gov

Start Date

June 10, 2013

End Date

December 31, 2014

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Azienda USL Reggio Emilia - IRCCS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eligible will be male and female patients \> 18 years of age.
•Eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating Centers, irrespective of the distance in time between stenting and surgery.
•Both candidates to elective/urgent operations and those undergoing emergency operations will be included in the SAS registry, and will be considered as two separate cohorts.

Exclusion Criteria

•Unwillingess/inability to sign the Informed Consent Form (ICF). There are no other selection criteria.

Outcomes

Primary Outcomes

The composite of death, myocardial infarction, probable/definite stent thrombosis according the Academic Research Consortium definition and bleeding events of Bleeding Academic Research Consortium (BARC)grade >3 during index surgical admission.

Time Frame: within the first 30 days after surgery

Secondary Outcomes

The incidence of bleeding events of Bleeding Academic Research Consortium (BARC) grade >3 within 30 days of index admission/procedure(within the first 30 days after surgery)