Coronary Artery DiseaseSPARTANCT02784405
Self-apposing Stentys Stents Registry
An observational study of Coronary Artery Disease, run by A.O.U. Città della Salute e della Scienza at 14 sites in 3 countries.
Trial summary
Self-apposing, drug-eluting Stentys coronary stents represent a valuable tool for the treatment of coronary artery stenosis. Their ability to adapt to widely varying vessel calibers and to auto-expand after their release to self-appose to vessel walls is particularly useful in the presence of ectasic coronary arteries… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 100 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Dec 2016to Nov 2018
- How long will I take part?
- 12 Months
- 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: Consecutive patients undergoing percutaneous treatment of coronary artery disease with implantation of a self-apposing, drug-eluting, Stentys stent
Who may be able to join
- ≥ 18 years old
- ability to provide informed consent
Who cannot join
- none
Trial locations and contacts
14 sites in 3 countries.
Antonio Montefusco, MD contact
14 sites in 3 countries
Italy12 sites, 12 recruiting
- Recruiting
Division of Cardiology, Mazzoni Hospital
Ascoli Piceno
Luciano Moretti, MD
Simona Silenzi, MD
- Recruiting
Ferrarotto Hospital, University of Catania
Catania
Alessio La Manna, MD
- Recruiting
Division of Cardiology, ASL TO4
Cirié
Pietro Gaetano, MD
- Recruiting
Division of Cardiology, Santa Maria dei Battuti Hospital
Conegliano
Andrea Pavei, MD
- Recruiting
Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi
Legnano
Arnaldo Poli, MD
- Recruiting
Interventional Cardiology, Azienda Ospedaliera Fatebenefratelli
Milan
Bernardo Cortese, MD
Bernardo Cortese, MD
- Recruiting
Division of Cardiology, Federico II University
Naples
Giovanni Esposito, MD, Prof
Plinio Cirillo, MD, Prof
- Recruiting
Division of Cardiology, Santa Corona Hospital
Pietra Ligure
Anna Maria Nicolino, MD
- Recruiting
Division of Cardiology, Fondazione Toscana G Monasterio
Pisa
Luigi Emilio Pastormerlo, MD
Cataldo Palmieri, MD
- Recruiting
Division of Cardiology, Policlinico Umberto I, La Sapienza University
Roma
Gennaro Sardella, MD
Massimo Mancone, MD
- Recruiting
Division of Cardiology, ASST Bergamo Ovest
Treviglio
Paolo Sganzerla, MD
- Recruiting
AO Città della Salute e della Scienza
Turin, 10126
Sebastiano Gili, MD, sebastiano.gili@gmail.com
Antonio Montefusco, MD, anto.montefusco@gmail.com
Malaysia1 site, 1 recruiting
- Recruiting
Cardiology Department, Manipal Klang Hospital
Kuala Selangor
Kuan Leong Yew, MD, Prof
Poland1 site, 1 recruiting
- Recruiting
Division of Cardiology, Medical University of Silesia
Katowice
Grzegorz Smolka, MD, Prof
About this study
Official title: Safety and Effectiveness of the Self-aPposing, bAlloon-delivered, dRug-eluting Stent for the Treatment of the Coronary Artery Disease: A multiCenter Registry
Self-apposing, drug-eluting Stentys coronary stents represent a valuable tool for the treatment of coronary artery stenosis. Their ability to adapt to widely varying vessel calibers and to auto-expand after their release to self-appose to vessel walls is particularly useful in the presence of ectasic coronary arteries or significant vessel tapering. The investigators planned this study to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.
Consecutive patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent were enrolled in this multi center registry. Inclusion criteria were age ≥ 18 years and ability to provide informed consent. No exclusion criteria were defined.
Primary end-point of the study is the occurrence of MACE (death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization). Secondary end-points include individual components of MACE, procedural complications (periprocedural MI, bleedings, access site complication, failure to cross stent struts with guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced nephropathy), bleedings at follow up.
Read the detailed description
Rationale: Choice of the appropriate size of stents in the treatment of coronary artery stenosis can often be challenging. Marked tapering of vessels' diameter in their proximal-distal development may lead to sub-optimal results. Distal under-expansion of the drug-eluting stent (DES) or vessel perforation may occur if a larger DES, best suited for the proximal diameter, is chosen. Proximal DES under-sizing with struts malapposition may happen if a smaller DES, fitting the distal diameter, is implanted. Moreover, ectasic vessels present irregular and varying diameter, which may lead as well to segmental malapposition or under-expansion of DES. Self-apposing stents can overcome these limitations thanks to their ability to self-expand also after their release in the vessel and to adapt to a wide range of vessel diameters. Multiple generation of self-apposing, drug-eluting stents have been developed, with progressive amendments pertaining the stent-deployment technique (from deployment by covering-sheath retraction to balloon-delivery) and the drug released (from paclitaxel to sirolimus). The last generation of the self-apposing stents is represented by the sirolimus-eluting, balloon-delivered Xposition S stents. Studies assessing performance of this stent are however limited in sample size and length of follow up, and are mainly controlled trials. Few data are available regarding the clinical outcomes of the self-apposing Stentys stents in a "real-life" setting.
Aim of this study is to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.
Study population: Patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent.
Primary analysis: Longitudinal cohort follow up
Study end-points:
Primary efficacy end-point:
- Major adverse cardiovascular events (MACE) (a composite end point including death, myocardial infarction (MI, excluding periprocedural MI), stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization (TLR))
Secondary efficacy end-points:
- Individual components of MACE (death, MI, stent thrombosis, unplanned hospitalization, TLR)
Secondary safety end-points:
- Procedural complications:
- Periprocedural MI
- Bleedings
- Access site complication
- Failure to cross stent struts with guidewire in the treatment of bifurcation
- Failure to delivery the stent
- Contrast-induced nephropathy
- Bleedings at follow up
- Conditions
- Coronary Artery Disease
- Keywords
- percutaneous coronary intervention, stent implantation
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
A composite end-point of death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization
Measured: 12 months
Secondary outcomes (7)
Death
Measured: 12 months
Myocardial Infarction
Incident rate of myocardial infarction
Measured: 12 months
Stent thrombosis
Incident rate of stent thrombosis
Measured: 12 months
Target lesion revascularization
Incident rate of target lesion revascularization
Measured: 12 months
Unplanned hospitalization for unstable angina
Incident rate of unplanned hospitalization for unstable angina
Measured: 12 months
Procedural and in-hospital complications
Incident rate of periprocedural myocardial infarction, bleedings and access site complication, failure to cross stent struts with guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced nephropathy
Measured: 30 days
Bleeding events
Incident rate of bleedings classified according to the BARC criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Moretti, A.O.U. Città della Salute e della Scienza
- Investigators
- Claudio Moretti, MD, Principal investigator, Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, ItalyAntonio Montefusco, MD, Principal investigator, Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, ItalyBernardo Cortese, MD, Principal investigator, Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784405
- Sponsor's protocol ID
- sparta2016
- Acronym
- SPARTA
- Status last verified
- Dec 2016
- First submitted
- 22 Apr 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lu H, IJsselmuiden AJ, Grundeken MJ, Nassif M, de Vries AG, Weevers A, Scholte M, Spaargaren R, Wykrzykowska JJ, Tijssen JG, de Winter RJ, Koch KT. First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting. EuroIntervention. 2016 Mar;11(12):1341-5. doi: 10.4244/EIJY15M05_07.
PubMed 25983027Pyxaras SA, Schmitz T, Naber CK. The STENTYS Self-Apposing(R) stent. EuroIntervention. 2015;11 Suppl V:V147-8. doi: 10.4244/EIJV11SVA34. No abstract available.
PubMed 25983152Farooq V, Gomez-Lara J, Brugaletta S, Gogas BD, Garcia-Garcia HM, Onuma Y, van Geuns RJ, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW. Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND Single Arm Study. Catheter Cardiovasc Interv. 2012 May 1;79(6):880-8. doi: 10.1002/ccd.23177. Epub 2011 Oct 5.
PubMed 22514149Uren NG, Schwarzacher SP, Metz JA, Lee DP, Honda Y, Yeung AC, Fitzgerald PJ, Yock PG; POST Registry Investigators. Predictors and outcomes of stent thrombosis: an intravascular ultrasound registry. Eur Heart J. 2002 Jan;23(2):124-32. doi: 10.1053/euhj.2001.2707.
PubMed 11785994Yew KL, Kang Z. First-in-man unprotected left main stenting with Stentys Xposition S self-apposing sirolimus eluting stent and optical coherence tomography guidance: The emerging panacea for left main intervention. Int J Cardiol. 2015 Dec 15;201:628-30. doi: 10.1016/j.ijcard.2015.08.035. Epub 2015 Aug 4. No abstract available.
PubMed 26340130Buccheri D, Orrego PS, Cortese B. Drug-eluting stent treatment of left main coronary artery disease: the case for a sirolimus-eluting, autoexpandable alternative. An optical coherence tomography analysis. Int J Cardiol. 2015 Nov 15;199:119-20. doi: 10.1016/j.ijcard.2015.07.006. Epub 2015 Jul 11. No abstract available.
PubMed 26188831van Geuns RJ, Yetgin T, La Manna A, Tamburino C, Souteyrand G, Motreff P, Koch KT, Vrolix M, IJsselmuiden A, Amoroso G, Berland J, Montalescot G, Teiger E, Christiansen EH, Spaargaren R, Wijns W. STENTYS Self-Apposing sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial. EuroIntervention. 2016 Feb;11(11):e1267-74. doi: 10.4244/EIJV11I11A248.
PubMed 26865444Yew KL. Longitudinal stent foreshortening of Stentys Xposition S self-apposing stents and its impact on overlapping stenting strategy. Int J Cardiol. 2016 Feb 1;204:187-8. doi: 10.1016/j.ijcard.2015.11.176. Epub 2015 Nov 25. No abstract available.
PubMed 26666346Montefusco A, D'Ascenzo F, Gili S, Smolka G, Chieffo A, Baumbach A, Escaned J, Sganzerla P, Tomassini F, Secco GG, Ugo F, Tamburino C, Nicolino A, Mancone M, Poli A, Yew KL, Cirillo P, Wanha W, Pastormerlo LE, di Summa R, Sardella G, Colombo A, Gaita F, Cortese B. Self-expandable sirolimus-eluting stents compared to second-generation drug-eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS-2 registries. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):208-215. doi: 10.1002/ccd.27809. Epub 2018 Oct 8.
PubMed 30298593
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the Self-aPposing, bAlloon-delivered, dRug-eluting Stent for the Treatment of the Coronary Artery Disease: A multiCenter Registry
- ClinicalTrials.gov ID
- NCT02784405
- Acronym / sponsor ID
- SPARTA / sparta2016
- Conditions
- Coronary Artery Disease
- Keywords
- percutaneous coronary intervention, stent implantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 27 May 2016 (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.
Self-apposing, drug-eluting Stentys coronary stents represent a valuable tool for the treatment of coronary artery stenosis. Their ability to adapt to widely varying vessel calibers and to auto-expand after their release to self-appose to vessel walls is particularly useful in the presence of ectasic coronary arteries or significant vessel tapering. The investigators planned this study to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.
Consecutive patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent were enrolled in this multi center registry. Inclusion criteria were age ≥ 18 years and ability to provide informed consent. No exclusion criteria were defined.
Primary end-point of the study is the occurrence of MACE (death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization). Secondary end-points include individual components of MACE, procedural complications (periprocedural MI, bleedings, access site complication, failure to cross stent struts with guidewire in the treatment of bifurcation, failure to delivery the stent, contrast-induced nephropathy), bleedings at follow up.
Detailed description
Rationale: Choice of the appropriate size of stents in the treatment of coronary artery stenosis can often be challenging. Marked tapering of vessels' diameter in their proximal-distal development may lead to sub-optimal results. Distal under-expansion of the drug-eluting stent (DES) or vessel perforation may occur if a larger DES, best suited for the proximal diameter, is chosen. Proximal DES under-sizing with struts malapposition may happen if a smaller DES, fitting the distal diameter, is implanted. Moreover, ectasic vessels present irregular and varying diameter, which may lead as well to segmental malapposition or under-expansion of DES. Self-apposing stents can overcome these limitations thanks to their ability to self-expand also after their release in the vessel and to adapt to a wide range of vessel diameters. Multiple generation of self-apposing, drug-eluting stents have been developed, with progressive amendments pertaining the stent-deployment technique (from deployment by covering-sheath retraction to balloon-delivery) and the drug released (from paclitaxel to sirolimus). The last generation of the self-apposing stents is represented by the sirolimus-eluting, balloon-delivered Xposition S stents. Studies assessing performance of this stent are however limited in sample size and length of follow up, and are mainly controlled trials. Few data are available regarding the clinical outcomes of the self-apposing Stentys stents in a "real-life" setting.
Aim of this study is to assess the feasibility, the effectiveness and the safety of the implantation of self-apposing, drug-eluting Stentys stents for percutaneous coronary intervention.
Study population: Patients undergoing percutaneous coronary intervention with implantation of a self-apposing Stentys stent.
Primary analysis: Longitudinal cohort follow up
Study end-points:
Primary efficacy end-point:
- Major adverse cardiovascular events (MACE) (a composite end point including death, myocardial infarction (MI, excluding periprocedural MI), stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization (TLR))
Secondary efficacy end-points:
- Individual components of MACE (death, MI, stent thrombosis, unplanned hospitalization, TLR)
Secondary safety end-points:
- Procedural complications:
- Periprocedural MI
- Bleedings
- Access site complication
- Failure to cross stent struts with guidewire in the treatment of bifurcation
- Failure to delivery the stent
- Contrast-induced nephropathy
- Bleedings at follow up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing percutaneous treatment of coronary artery disease with implantation of a self-apposing, drug-eluting, Stentys stent
Key inclusion criteria (2 listed)
- ≥ 18 years old
- ability to provide informed consent
Key exclusion criteria (1 listed)
- none
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
Major Adverse Cardiovascular Events (MACE)
Time frame: 12 months
A composite end-point of death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization
7 secondary outcomes
Death
Time frame: 12 months
Myocardial Infarction
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
Target lesion revascularization
Time frame: 12 months
Unplanned hospitalization for unstable angina
Time frame: 12 months
Procedural and in-hospital complications
Time frame: 30 days
Bleeding events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Background: PubMed 25983027Lu H, IJsselmuiden AJ, Grundeken MJ, Nassif M, de Vries AG, Weevers A, Scholte M, Spaargaren R, Wykrzykowska JJ, Tijssen JG, de Winter RJ, Koch KT. First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting. EuroIntervention. 2016 Mar;11(12):1341-5. doi: 10.4244/EIJY15M05_07.
- Background: PubMed 25983152Pyxaras SA, Schmitz T, Naber CK. The STENTYS Self-Apposing(R) stent. EuroIntervention. 2015;11 Suppl V:V147-8. doi: 10.4244/EIJV11SVA34. No abstract available.
- Background: PubMed 22514149Farooq V, Gomez-Lara J, Brugaletta S, Gogas BD, Garcia-Garcia HM, Onuma Y, van Geuns RJ, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW. Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND Single Arm Study. Catheter Cardiovasc Interv. 2012 May 1;79(6):880-8. doi: 10.1002/ccd.23177. Epub 2011 Oct 5.
- Background: PubMed 11785994Uren NG, Schwarzacher SP, Metz JA, Lee DP, Honda Y, Yeung AC, Fitzgerald PJ, Yock PG; POST Registry Investigators. Predictors and outcomes of stent thrombosis: an intravascular ultrasound registry. Eur Heart J. 2002 Jan;23(2):124-32. doi: 10.1053/euhj.2001.2707.
- Background: PubMed 26340130Yew KL, Kang Z. First-in-man unprotected left main stenting with Stentys Xposition S self-apposing sirolimus eluting stent and optical coherence tomography guidance: The emerging panacea for left main intervention. Int J Cardiol. 2015 Dec 15;201:628-30. doi: 10.1016/j.ijcard.2015.08.035. Epub 2015 Aug 4. No abstract available.
- Background: PubMed 26188831Buccheri D, Orrego PS, Cortese B. Drug-eluting stent treatment of left main coronary artery disease: the case for a sirolimus-eluting, autoexpandable alternative. An optical coherence tomography analysis. Int J Cardiol. 2015 Nov 15;199:119-20. doi: 10.1016/j.ijcard.2015.07.006. Epub 2015 Jul 11. No abstract available.
- Background: PubMed 26865444van Geuns RJ, Yetgin T, La Manna A, Tamburino C, Souteyrand G, Motreff P, Koch KT, Vrolix M, IJsselmuiden A, Amoroso G, Berland J, Montalescot G, Teiger E, Christiansen EH, Spaargaren R, Wijns W. STENTYS Self-Apposing sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial. EuroIntervention. 2016 Feb;11(11):e1267-74. doi: 10.4244/EIJV11I11A248.
- Background: PubMed 26666346Yew KL. Longitudinal stent foreshortening of Stentys Xposition S self-apposing stents and its impact on overlapping stenting strategy. Int J Cardiol. 2016 Feb 1;204:187-8. doi: 10.1016/j.ijcard.2015.11.176. Epub 2015 Nov 25. No abstract available.
- Derived from this study: PubMed 30298593Montefusco A, D'Ascenzo F, Gili S, Smolka G, Chieffo A, Baumbach A, Escaned J, Sganzerla P, Tomassini F, Secco GG, Ugo F, Tamburino C, Nicolino A, Mancone M, Poli A, Yew KL, Cirillo P, Wanha W, Pastormerlo LE, di Summa R, Sardella G, Colombo A, Gaita F, Cortese B. Self-expandable sirolimus-eluting stents compared to second-generation drug-eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS-2 registries. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):208-215. doi: 10.1002/ccd.27809. Epub 2018 Oct 8.
- Individual participant dataSharing planned: No
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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.
Antonio Montefusco, MD contact
Claudio Moretti, MD principal investigator
Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy
Antonio Montefusco, MD principal investigator
Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy
Bernardo Cortese, MD principal investigator
Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by A.O.U. Città della Salute e della Scienza at 14 sites in 3 countries.
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: status not confirmed, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, Malaysia, Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastiano Gili, MD (+393338354923, sebastiano.gili@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (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 NCT02784405, which also lists 9 linked publications.
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 19 Dec 2016.