Self-apposing Stentys Stents Registry

Coronary Artery Disease Clinical Trial

— SPARTA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02784405
• Other study ID #: sparta2016
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2016
• Last updated: December 16, 2016
• Start date: December 2016
• Est. completion date: November 2018

Study information

• Verified date: December 2016
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Sebastiano Gili, MD
• Phone: +393338354923
• Email: sebastiano.gili[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old

• ability to provide informed consent

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	Division of Cardiology, Mazzoni Hospital	Ascoli Piceno
Italy	Ferrarotto Hospital, University of Catania	Catania
Italy	Division of Cardiology, ASL TO4	Cirie
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
Malaysia	Cardiology Department, Manipal Klang Hospital	Selangor
Poland	Division of Cardiology, Medical University of Silesia	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Countries where clinical trial is conducted

Italy,  Malaysia,  Poland, 

References & Publications (8)

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. — View Citation

Farooq V, Gomez-Lara J, Brugaletta S, Gogas BD, Garcìa-Garcìa 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. — View Citation

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. — View Citation

Pyxaras SA, Schmitz T, Naber CK. The STENTYS Self-Apposing® stent. EuroIntervention. 2015;11 Suppl V:V147-8. doi: 10.4244/EIJV11SVA34. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events (MACE)	A composite end-point of death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization	12 months	No
Secondary	Death		12 months	No
Secondary	Myocardial Infarction	Incident rate of myocardial infarction	12 months	No
Secondary	Stent thrombosis	Incident rate of stent thrombosis	12 months	No
Secondary	Target lesion revascularization	Incident rate of target lesion revascularization	12 months	No
Secondary	Unplanned hospitalization for unstable angina	Incident rate of unplanned hospitalization for unstable angina	12 months	No
Secondary	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	30 days	No
Secondary	Bleeding events	Incident rate of bleedings classified according to the BARC criteria	12 months	No