The Surgery After Stenting (SAS) Registry

SURGERY Clinical Trial

— SAS registry  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01997242
• Other study ID #: ASMN-18/2013
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2013
• Last updated: April 24, 2014
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2013
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: Stefano Savonitto, MD
• Phone: +39-0341-489490
• Email: s.savonitto[@]ospedale.lecco.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• PERCUTANEOUS CORONARY INTERVENTION
• STENTS
• SURGERY

Locations

Country	Name	City	State
Italy	Arcispedale Santa Maria Nuova- IRCCS	Reggio Emilia

Sponsors (3)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS	Associazione Nazionale Medici Cardiologi Ospedalieri, Italian Society of Invasive Cardiology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes