The Surgery After Stenting (SAS) Registry

NCT01997242 | Completed DMC

• 1 other identifier: ASMN-18/2013
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

PERCUTANEOUS CORONARY INTERVENTION; STENTS; SURGERY

Keywords

CORONARY STENT; CARDIAC SURGERY; NON CARDIAC SURGEY

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

stenting undergoing surgery

Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Italian Society of Invasive Cardiology: collaborator
• Associazione Nazionale Medici Cardiologi Ospedalieri: collaborator

Study Sites (1)

Arcispedale Santa Maria Nuova- IRCCS

Reggio Emilia, Italy, 42123, Italy

Location

Study Officials

• Stefano Savonitto, MD

  Division of Cardiology, Manzoni Hospital, Lecco

  STUDY CHAIR

• Roberta Rossini, MD

  Cardiovascular Dpt, Ospedali Riuniti di Bergamo

  STUDY CHAIR

• Giovanni Tortorella, MD

  Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia

  STUDY CHAIR

• Marco Ferri, MD

  Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2013
• First Posted: November 28, 2013
• Study Start: June 10, 2013
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

IT (1)