In-stent Coronary Artery RestenosisLATINANCT01411475
Prognostic Assessment of Different Pattern of Bifurcation Restenosis
An observational study of In-stent Coronary Artery Restenosis, run by Ospedale Santa Maria Goretti at 2 sites in Italy.
Trial summary
The LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- In-stent Coronary Artery Restenosis
- What is being tested?
- Bifurcation restenosis classification
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Aug 2011to Aug 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Coronary artery disease
Who may be able to join
- age >18 years
- restenosis involving a coronary bifurcation previously treated percutaneously
Who cannot join
- life expectancy >1 year
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Classification of Bifurcation Restenosis: a Prognostic Assessment
The LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention.
- Conditions
- In-stent Coronary Artery Restenosis
- Being tested
- Bifurcation restenosis classification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifurcation restenosis classificationOther
Classification of restenosis involving coronary bifurcation according to their pattern
| Study group | Role | What they receive |
|---|---|---|
| Bifurcation restenosis | Patients with either a main vessel or a side branch restenosis following succesful percutaneous coronary intervention Receives: Other: Bifurcation restenosis classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Number of patients experiencing any of the following events: cardiac death, non-fatal miocardial infarction, target vessel revascularization
Measured: 12 months
Secondary outcomes (3)
Cardiac death
Number of patients experiencing a cardiac death event
Measured: 12
Non-fatal myocardial infarction
Number of patients experiencing a non-fatal myocardial infarction event
Measured: 12 months
Target vessel revascularization
Number of patients experiencing a target vessel revascularization event
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2011 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for In-stent Coronary Artery RestenosisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Maria Goretti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Sgueglia, MD, Ospedale Santa Maria Goretti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411475
- Sponsor's protocol ID
- SMG-009
- Acronym
- LATINA
- Status last verified
- Feb 2020
- First submitted
- 5 Aug 2011
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Sgueglia GA, Todaro D, Stipo A, Pucci E. Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: a concept series. J Invasive Cardiol. 2011 Nov;23(11):474-6.
PubMed 22045082
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Bifurcation Restenosis: a Prognostic Assessment
- ClinicalTrials.gov ID
- NCT01411475
- Acronym / sponsor ID
- LATINA / SMG-009
- Conditions
- In-stent Coronary Artery Restenosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ospedale Santa Maria GorettiUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 8 Aug 2011 (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 LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bifurcation restenosis | – | Other: Bifurcation restenosis classificationPatients with either a main vessel or a side branch restenosis following succesful percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary artery disease
Key inclusion criteria (2 listed)
- age >18 years
- restenosis involving a coronary bifurcation previously treated percutaneously
Key exclusion criteria (1 listed)
- life expectancy >1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifurcation restenosis classificationClassification of restenosis involving coronary bifurcation according to their pattern | Other | Bifurcation restenosis |
Primary outcome
Major adverse cardiac events
Time frame: 12 months
Number of patients experiencing any of the following events: cardiac death, non-fatal miocardial infarction, target vessel revascularization
3 secondary outcomes
Cardiac death
Time frame: 12
Non-fatal myocardial infarction
Time frame: 12 months
Target vessel revascularization
Time frame: 12 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 22045082Sgueglia GA, Todaro D, Stipo A, Pucci E. Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: a concept series. J Invasive Cardiol. 2011 Nov;23(11):474-6.
Related trials for In-stent Coronary Artery Restenosis
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Recruiting
Virtue® SAB in the Treatment of Coronary ISR Trial
Coronary Artery Disease
Recruiting
Prevail Global Study
Coronary Artery Disease
Active, not recruiting
SELUTION SLR™ 014 In-stent Restenosis
Coronary Restenosis
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-stent Coronary Artery Restenosis, run by Ospedale Santa Maria Goretti at 2 sites 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 2 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: withdrawn, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Major adverse cardiac events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411475, which also lists 1 linked publication.
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 25 Feb 2020.