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The Surgery After Stenting (SAS) Registry

Conditions
PERCUTANEOUS CORONARY INTERVENTION
STENTS
SURGERY
Registration Number
NCT01997242
Lead Sponsor
Arcispedale Santa Maria Nuova-IRCCS
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
500
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.within the first 30 days after surgery
Secondary Outcome Measures
NameTimeMethod
The incidence of bleeding events of Bleeding Academic Research Consortium (BARC) grade >3 within 30 days of index admission/procedurewithin the first 30 days after surgery

Trial Locations

Locations (1)

Arcispedale Santa Maria Nuova- IRCCS

🇮🇹

Reggio Emilia, Italy

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