Self-apposing Stentys Stents Registry

NCT02784405 | Unknown

• 1 other identifier: sparta2016
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 14

Brief 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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; stent implantation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Death

  12 months

• Myocardial Infarction

  12 months

• Stent thrombosis

  12 months

• Target lesion revascularization

  12 months

• Unplanned hospitalization for unstable angina

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing percutaneous treatment of coronary artery disease with implantation of a self-apposing, drug-eluting, Stentys stent

You may qualify if:

• ≥ 18 years old
• ability to provide informed consent

You may not qualify if:

• none

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (14)

Division of Cardiology, Mazzoni Hospital

Ascoli Piceno, Italy

RECRUITING

Ferrarotto Hospital, University of Catania

Catania, Italy

RECRUITING

Division of Cardiology, ASL TO4

Cirié, Italy

RECRUITING

Division of Cardiology, Santa Maria dei Battuti Hospital

Conegliano, Italy

RECRUITING

Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi

Legnano, Italy

RECRUITING

Interventional Cardiology, Azienda Ospedaliera Fatebenefratelli

Milan, Italy

RECRUITING

Division of Cardiology, Federico II University

Napoli, Italy

RECRUITING

Division of Cardiology, Santa Corona Hospital

Pietra Ligure, Italy

RECRUITING

Division of Cardiology, Fondazione Toscana G Monasterio

Pisa, Italy

RECRUITING

Division of Cardiology, Policlinico Umberto I, La Sapienza University

Roma, Italy

RECRUITING

Division of Cardiology, ASST Bergamo Ovest

Treviglio, Italy

RECRUITING

AO Città della Salute e della Scienza

Turin, 10126, Italy

RECRUITING

Cardiology Department, Manipal Klang Hospital

Kuala Selangor, Malaysia

RECRUITING

Division of Cardiology, Medical University of Silesia

Katowice, Poland

RECRUITING

Related Publications (9)

• 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.

  PMID: 25983027 BACKGROUND

• 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.

  PMID: 25983152 BACKGROUND

• 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.

  PMID: 22514149 BACKGROUND

• 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.

  PMID: 11785994 BACKGROUND

• 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.

  PMID: 26340130 BACKGROUND

• 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.

  PMID: 26188831 BACKGROUND

• 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.

  PMID: 26865444 BACKGROUND

• 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.

  PMID: 26666346 BACKGROUND

• 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.

  PMID: 30298593 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Claudio Moretti, MD

  Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy

  PRINCIPAL INVESTIGATOR

• Antonio Montefusco, MD

  Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy

  PRINCIPAL INVESTIGATOR

• Bernardo Cortese, MD

  Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastiano Gili, MD

CONTACT

+393338354923; sebastiano.gili@gmail.com

Antonio Montefusco, MD

CONTACT

anto.montefusco@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 27, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: November 1, 2018
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); IT (12); MY (1)