ST Segment Elevation Myocardial InfarctioniPOSITIONNCT02979236
Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMI
An observational study of ST Segment Elevation Myocardial Infarction, run by UOSD Emodinamica Diagnostica e Interventistica at 8 sites in Italy.
Trial summary
The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST segment elevation myocardial infarction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction
- What is being tested?
- STENTYS Xposition S
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 8 sitesItaly
- Study dates
- Jun 2016to Dec 2018
- 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 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment).
Who may be able to join
- Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment).
Who cannot join
- Cardiogenic shock
- Multiple lesions requiring stenting in the target vessel.
- Highly calcified lesions or excessive tortuosity at target lesion site.
- Intrastent pathology.
- Subject unable to take or comply with dual antiplatelet therapy as recommended per guidelines.
- Female subjects of childbearing potential known to be pregnant.
Show all 9Show fewer
- Co-morbidities with life expectancy less than 1 year
- Patient unable to provide written informed consent.
- Known allergies to stent component.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Not yet recruiting
Dipartimento cardiotoracico e vascolare - S.S Emodinamica Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo.
Alessandria, Alessandria, 15121
Gioel Gabrio Secco, MD PhD, gioel.gabrio.secco@gmail.com
- Not yet recruiting
UOC Cardiologia- UTIC Ospedale Civile "C. e G.Mazzoni"
Ascoli Piceno, Ascoli Piceno, 63100
Pierfrancesco Grossi, MD, p.f.grossi@tiscali.it
- Recruiting
UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata
Chieti, Chieti, 66100
Livio Giuliani, MD PhD, 3473690091, lvgiuliani@gmail.com
Serena Rossi, MD, 3286721396, rossisere.rs@gmail.com
- Recruiting
UOC Terapia cardiologica intensiva ed interventistica Azienda Ospedaliera Universitaria G. Martino
Messina, Messina, 98121
Franco Saporito, MD, fsaporito@unime.it
- Not yet recruiting
UOC Cardiologia Emodinamica Ospedale San Salvatore - Centrale
Pesaro, Pesaro
Rosario Alessandro Parisi, MD, saroparisi@hotmail.it
- Not yet recruiting
UOC UTIC e Cardiologia Interventistica Ospedale S. Spirito
Pescara, Pescara, 65121
Leonardo Paloscia, MD, leonardo.paloscia@auls.pe.it
- Recruiting
UOC Emodinamica Ospedale Umberto I
Syracuse, Siracusa, 96100
Marco Contarini, MD, marcocontarini@gmail.com
Giorgio Sacchetta, MD, giorgiosacchetta@gmail.com
- Not yet recruiting
S.S. Emodinamica Ospedale San Giovanni Bosco
Torino, Torino, 10154
Roberto Garbo, MD, r.garbo68@gmail.com
Fabrizio Ugo, MD, ugo.fabrizio@tiscali.it
About this study
Official title: Prospective, Observational, Italian Multi-center Registry of Self-aPposing cOronary Stent in Patients Presenting With ST-segment Elevation Myocardial InfarcTION: the iPOSITION Registry
The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST segment elevation myocardial infarction
- Being tested
- STENTYS Xposition S
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STENTYS Xposition SDevice
| Study group | Role | What they receive |
|---|---|---|
| STEMI treated with STENTYS Xposition S | Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment). Receives: Device: STENTYS Xposition S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
target lesion failure will be assessed as the composite of cardiac death; recurrent Target Vessel-Related Myocardial Infarction (MI) and clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods (CABG).
Measured: 12 months post procedure
Secondary outcomes (4)
Procedural success without the occurrence of death and repeat ischemia-driven revascularization of the target lesion during the hospital stay
Measured: during the hospitalization, an average of 6 days
Target lesion failure at 30-day post-procedure
Measured: 30 day post procedure
Death from any cause
Measured: 12 months post procedure
Stent thrombosis rate at 30-day and 12-months after the procedure
Measured: 30 days post procedure and 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ST Segment Elevation Myocardial InfarctionStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UOSD Emodinamica Diagnostica e Interventistica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livio Giuliani, UOSD Emodinamica Diagnostica e Interventistica
- Investigators
- Livio Giuliani, MD PhD, Principal investigator, UOSD Emodinamica Diagnostica e Interventistica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979236
- Sponsor's protocol ID
- CH2016-01
- Acronym
- iPOSITION
- Status last verified
- Nov 2016
- First submitted
- 24 Nov 2016
- Last updated
- 1 Dec 2016
- Results posted
- No
Publications
Kim YS, Koo BK, Seo JB, Park KW, Suh JW, Lee HY, Park JS, Kang HJ, Cho YS, Chung WY, Chae IH, Choi DJ, Kim HS, Oh BH, Park YB. The incidence and predictors of postprocedural incomplete stent apposition after angiographically successful drug-eluting stent implantation. Catheter Cardiovasc Interv. 2009 Jul 1;74(1):58-63. doi: 10.1002/ccd.21961.
PubMed 19360868Gutierrez-Chico JL, Regar E, Nuesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18.
PubMed 21768536Foin N, Gutierrez-Chico JL, Nakatani S, Torii R, Bourantas CV, Sen S, Nijjer S, Petraco R, Kousera C, Ghione M, Onuma Y, Garcia-Garcia HM, Francis DP, Wong P, Di Mario C, Davies JE, Serruys PW. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014 Apr;7(2):180-9. doi: 10.1161/CIRCINTERVENTIONS.113.000931. Epub 2014 Mar 18.
PubMed 24642998Cook S, Eshtehardi P, Kalesan B, Raber L, Wenaweser P, Togni M, Moschovitis A, Vogel R, Seiler C, Eberli FR, Luscher T, Meier B, Juni P, Windecker S. Impact of incomplete stent apposition on long-term clinical outcome after drug-eluting stent implantation. Eur Heart J. 2012 Jun;33(11):1334-43. doi: 10.1093/eurheartj/ehr484. Epub 2012 Jan 26.
PubMed 22285579Nakano M, Yahagi K, Otsuka F, Sakakura K, Finn AV, Kutys R, Ladich E, Fowler DR, Joner M, Virmani R. Causes of early stent thrombosis in patients presenting with acute coronary syndrome: an ex vivo human autopsy study. J Am Coll Cardiol. 2014 Jun 17;63(23):2510-2520. doi: 10.1016/j.jacc.2014.02.607. Epub 2014 Apr 23.
PubMed 24768883Amoroso G, van Geuns RJ, Spaulding C, Manzo-Silberman S, Hauptmann KE, Spaargaren R, Garcia-Garcia HM, Serruys PW, Verheye S. Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study. EuroIntervention. 2011 Aug;7(4):428-36. doi: 10.4244/EIJV7I4A71.
PubMed 21764660van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Garcia-Garcia HM, Regar E, Capodanno D, Van Langenhove G, Verheye S. Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Dec;5(12):1209-19. doi: 10.1016/j.jcin.2012.08.016.
PubMed 23257368Koch KT, Grundeken MJ, Vos NS, IJsselmuiden AJ, van Geuns RJ, Wessely R, Dengler T, La Manna A, Silvain J, Montalescot G, Spaargaren R, Tijssen JG, Amoroso G. One-year clinical outcomes of the STENTYS Self-Apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: results from the APPOSITION III registry. EuroIntervention. 2015 Jul;11(3):264-71. doi: 10.4244/EIJY15M02_08.
PubMed 25692610van 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 26865444Grundeken MJ, Lu H, Mehran R, Cutlip DE, Leon MB, Yeung A, Koch KT, Montalescot G, van Geuns RJ, Spaargaren R, Buchbinder M. APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction--rationale and design. Am Heart J. 2014 Nov;168(5):652-60. doi: 10.1016/j.ahj.2014.07.011. Epub 2014 Jul 24.
PubMed 25440792Sianos G, Papafaklis MI, Serruys PW. Angiographic thrombus burden classification in patients with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention. J Invasive Cardiol. 2010 Oct;22(10 Suppl B):6B-14B.
PubMed 20947930
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Italian Multi-center Registry of Self-aPposing cOronary Stent in Patients Presenting With ST-segment Elevation Myocardial InfarcTION: the iPOSITION Registry
- ClinicalTrials.gov ID
- NCT02979236
- Acronym / sponsor ID
- iPOSITION / CH2016-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- UOSD Emodinamica Diagnostica e InterventisticaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 1 Dec 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.
The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST segment elevation myocardial infarction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI treated with STENTYS Xposition S | – | Device: STENTYS Xposition SPatients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment).
Key inclusion criteria (1 listed)
- Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment).
Key exclusion criteria (9 listed)
- Cardiogenic shock
- Multiple lesions requiring stenting in the target vessel.
- Highly calcified lesions or excessive tortuosity at target lesion site.
- Intrastent pathology.
- Subject unable to take or comply with dual antiplatelet therapy as recommended per guidelines.
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 |
|---|---|---|
| STENTYS Xposition S | Device | STEMI treated with STENTYS Xposition S |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months post procedure
target lesion failure will be assessed as the composite of cardiac death; recurrent Target Vessel-Related Myocardial Infarction (MI) and clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods (CABG).
4 secondary outcomes
Procedural success without the occurrence of death and repeat ischemia-driven revascularization of the target lesion during the hospital stay
Time frame: during the hospitalization, an average of 6 days
Target lesion failure at 30-day post-procedure
Time frame: 30 day post procedure
Death from any cause
Time frame: 12 months post procedure
Stent thrombosis rate at 30-day and 12-months after the procedure
Time frame: 30 days post procedure and 12 months post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Background: PubMed 19360868Kim YS, Koo BK, Seo JB, Park KW, Suh JW, Lee HY, Park JS, Kang HJ, Cho YS, Chung WY, Chae IH, Choi DJ, Kim HS, Oh BH, Park YB. The incidence and predictors of postprocedural incomplete stent apposition after angiographically successful drug-eluting stent implantation. Catheter Cardiovasc Interv. 2009 Jul 1;74(1):58-63. doi: 10.1002/ccd.21961.
- Background: PubMed 21768536Gutierrez-Chico JL, Regar E, Nuesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18.
- Background: PubMed 24642998Foin N, Gutierrez-Chico JL, Nakatani S, Torii R, Bourantas CV, Sen S, Nijjer S, Petraco R, Kousera C, Ghione M, Onuma Y, Garcia-Garcia HM, Francis DP, Wong P, Di Mario C, Davies JE, Serruys PW. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014 Apr;7(2):180-9. doi: 10.1161/CIRCINTERVENTIONS.113.000931. Epub 2014 Mar 18.
- Background: PubMed 22285579Cook S, Eshtehardi P, Kalesan B, Raber L, Wenaweser P, Togni M, Moschovitis A, Vogel R, Seiler C, Eberli FR, Luscher T, Meier B, Juni P, Windecker S. Impact of incomplete stent apposition on long-term clinical outcome after drug-eluting stent implantation. Eur Heart J. 2012 Jun;33(11):1334-43. doi: 10.1093/eurheartj/ehr484. Epub 2012 Jan 26.
- Background: PubMed 24768883Nakano M, Yahagi K, Otsuka F, Sakakura K, Finn AV, Kutys R, Ladich E, Fowler DR, Joner M, Virmani R. Causes of early stent thrombosis in patients presenting with acute coronary syndrome: an ex vivo human autopsy study. J Am Coll Cardiol. 2014 Jun 17;63(23):2510-2520. doi: 10.1016/j.jacc.2014.02.607. Epub 2014 Apr 23.
- Background: PubMed 21764660Amoroso G, van Geuns RJ, Spaulding C, Manzo-Silberman S, Hauptmann KE, Spaargaren R, Garcia-Garcia HM, Serruys PW, Verheye S. Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study. EuroIntervention. 2011 Aug;7(4):428-36. doi: 10.4244/EIJV7I4A71.
- Background: PubMed 23257368van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Garcia-Garcia HM, Regar E, Capodanno D, Van Langenhove G, Verheye S. Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Dec;5(12):1209-19. doi: 10.1016/j.jcin.2012.08.016.
- Background: PubMed 25692610Koch KT, Grundeken MJ, Vos NS, IJsselmuiden AJ, van Geuns RJ, Wessely R, Dengler T, La Manna A, Silvain J, Montalescot G, Spaargaren R, Tijssen JG, Amoroso G. One-year clinical outcomes of the STENTYS Self-Apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: results from the APPOSITION III registry. EuroIntervention. 2015 Jul;11(3):264-71. doi: 10.4244/EIJY15M02_08.
- 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 25440792Grundeken MJ, Lu H, Mehran R, Cutlip DE, Leon MB, Yeung A, Koch KT, Montalescot G, van Geuns RJ, Spaargaren R, Buchbinder M. APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction--rationale and design. Am Heart J. 2014 Nov;168(5):652-60. doi: 10.1016/j.ahj.2014.07.011. Epub 2014 Jul 24.
- Background: PubMed 20947930Sianos G, Papafaklis MI, Serruys PW. Angiographic thrombus burden classification in patients with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention. J Invasive Cardiol. 2010 Oct;22(10 Suppl B):6B-14B.
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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.
Livio Giuliani, MD PhD principal investigator
UOSD Emodinamica Diagnostica e Interventistica
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Segment Elevation Myocardial Infarction, run by UOSD Emodinamica Diagnostica e Interventistica at 8 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 1 inclusion and 9 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 1 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 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Livio Giuliani, MD PhD (347360091, lvgiuliani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 months post procedure). 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 NCT02979236, which also lists 11 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 1 Dec 2016.