Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2016-12-31
2018-11-30
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ability to provide informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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A.O.U. Città della Salute e della Scienza
OTHER
Responsible Party
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Claudio Moretti
MD
Principal Investigators
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Claudio Moretti, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy
Antonio Montefusco, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy
Bernardo Cortese, MD
Role: PRINCIPAL_INVESTIGATOR
Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy
Locations
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Division of Cardiology, Mazzoni Hospital
Ascoli Piceno, , Italy
Ferrarotto Hospital, University of Catania
Catania, , Italy
Division of Cardiology, ASL TO4
Cirié, , Italy
Division of Cardiology, Santa Maria dei Battuti Hospital
Conegliano, , Italy
Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi
Legnano, , Italy
Interventional Cardiology, Azienda Ospedaliera Fatebenefratelli
Milan, , Italy
Division of Cardiology, Federico II University
Napoli, , Italy
Division of Cardiology, Santa Corona Hospital
Pietra Ligure, , Italy
Division of Cardiology, Fondazione Toscana G Monasterio
Pisa, , Italy
Division of Cardiology, Policlinico Umberto I, La Sapienza University
Roma, , Italy
Division of Cardiology, ASST Bergamo Ovest
Treviglio, , Italy
AO Città della Salute e della Scienza
Turin, , Italy
Cardiology Department, Manipal Klang Hospital
Kuala Selangor, , Malaysia
Division of Cardiology, Medical University of Silesia
Katowice, , Poland
Countries
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Central Contacts
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Facility Contacts
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Luciano Moretti, MD
Role: primary
Simona Silenzi, MD
Role: backup
Alessio La Manna, MD
Role: primary
Pietro Gaetano, MD
Role: primary
Andrea Pavei, MD
Role: primary
Arnaldo Poli, MD
Role: primary
Bernardo Cortese, MD
Role: primary
Giovanni Esposito, MD, Prof
Role: primary
Plinio Cirillo, MD, Prof
Role: backup
Anna Maria Nicolino, MD
Role: primary
Luigi Emilio Pastormerlo, MD
Role: primary
Cataldo Palmieri, MD
Role: backup
Gennaro Sardella, MD
Role: primary
Massimo Mancone, MD
Role: backup
Paolo Sganzerla, MD
Role: primary
Sebastiano Gili, MD
Role: primary
Antonio Montefusco, MD
Role: backup
Kuan Leong Yew, MD, Prof
Role: primary
Grzegorz Smolka, MD, Prof
Role: primary
References
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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.
Pyxaras 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.
Farooq 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.
Uren 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.
Yew 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.
Buccheri 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.
van 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.
Yew 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.
Montefusco 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.
Other Identifiers
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sparta2016
Identifier Type: -
Identifier Source: org_study_id