PERCUTANEOUS CORONARY INTERVENTIONSAS registryNCT01997242
The Surgery After Stenting (SAS) Registry
An observational study of PERCUTANEOUS CORONARY INTERVENTION and STENTS, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PERCUTANEOUS CORONARY INTERVENTION, STENTS, SURGERY
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2013to 31 Dec 2014
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures
Who may be able to join
- 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.
Who cannot join
- Unwillingess/inability to sign the Informed Consent Form (ICF). There are no other selection criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Registry of Consecutive Patients Undergoing Cardiac and Noncardiac Surgery or Operative Endoscopic/Endovascular Procedures After Implantation of a Coronary Stent
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| stenting undergoing surgery | Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study start10 Jun 2013
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PERCUTANEOUS CORONARY INTERVENTIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- Italian Society of Invasive Cardiology, Associazione Nazionale Medici Cardiologi Ospedalieri
- Responsible party
- Sponsor
- Investigators
- Stefano Savonitto, MD, Study chair, Division of Cardiology, Manzoni Hospital, LeccoRoberta Rossini, MD, Study chair, Cardiovascular Dpt, Ospedali Riuniti di BergamoGiovanni Tortorella, MD, Study chair, Arcispedale Santa Maria Nuova - IRCCS, Reggio EmiliaMarco Ferri, MD, Principal investigator, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997242
- Sponsor's protocol ID
- ASMN-18/2013
- Acronym
- SAS registry
- Status last verified
- Jun 2025
- First submitted
- 14 Sep 2013
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry of Consecutive Patients Undergoing Cardiac and Noncardiac Surgery or Operative Endoscopic/Endovascular Procedures After Implantation of a Coronary Stent
- ClinicalTrials.gov ID
- NCT01997242
- Acronym / sponsor ID
- SAS registry / ASMN-18/2013
- Conditions
- PERCUTANEOUS CORONARY INTERVENTION, STENTS, SURGERY
- Keywords
- CORONARY STENT, CARDIAC SURGERY, NON CARDIAC SURGEY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- Italian Society of Invasive Cardiology, Associazione Nazionale Medici Cardiologi Ospedalieri
- Study start
- 10 Jun 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stenting undergoing surgery | – | –Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwillingess/inability to sign the Informed Consent Form (ICF). There are no other selection criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Savonitto, MD study chair
Division of Cardiology, Manzoni Hospital, Lecco
Roberta Rossini, MD study chair
Cardiovascular Dpt, Ospedali Riuniti di Bergamo
Giovanni Tortorella, MD study chair
Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PERCUTANEOUS CORONARY INTERVENTION and STENTS, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.