The Surgery After Stenting (SAS) Registry (SAS registry)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Arcispedale Santa Maria Nuova-IRCCS
Sponsor:
Collaborators:
Italian Society of Invasive Cardiology
Associazione Nazionale Medici Cardiologi Ospedalieri
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier:
NCT01997242
First received: September 14, 2013
Last updated: April 24, 2014
Last verified: September 2013
  Purpose

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).


Condition
PERCUTANEOUS CORONARY INTERVENTION
STENTS
SURGERY

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: A Multicenter Registry of Consecutive Patients Undergoing Cardiac and Noncardiac Surgery or Operative Endoscopic/Endovascular Procedures After Implantation of a Coronary Stent

Resource links provided by NLM:


Further study details as provided by Arcispedale Santa Maria Nuova-IRCCS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The incidence of bleeding events of Bleeding Academic Research Consortium (BARC) grade >3 within 30 days of index admission/procedure [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: June 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
stenting undergoing surgery
Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997242

Contacts
Contact: Stefano Savonitto, MD +39-0341-489490 s.savonitto@ospedale.lecco.it
Contact: Roberta Rossini, MD +39-035-2673446 roberta_rossini@yahoo.it

Locations
Italy
Arcispedale Santa Maria Nuova- IRCCS Recruiting
Reggio Emilia, Italy, 42123
Contact: Stefano Savonitto, MD    +39-0341-489490    s.savonitto@ospedale.lecco.it   
Contact: Roberta Rossini, MD       roberta_rossini@yahoo.it   
Principal Investigator: Giovanni Tortorella, MD         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Italian Society of Invasive Cardiology
Associazione Nazionale Medici Cardiologi Ospedalieri
Investigators
Study Chair: Stefano Savonitto, MD Division of Cardiology, Manzoni Hospital, Lecco
Study Chair: Roberta Rossini, MD Cardiovascular Dpt, Ospedali Riuniti di Bergamo
Principal Investigator: Giovanni Tortorella, MD Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia
  More Information

No publications provided

Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT01997242     History of Changes
Other Study ID Numbers: ASMN-18/2013
Study First Received: September 14, 2013
Last Updated: April 24, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
CORONARY STENT
CARDIAC SURGERY
NON CARDIAC SURGEY

ClinicalTrials.gov processed this record on July 22, 2014