Clinical trial NCT02784405: Self-apposing Stentys Stents Registry
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: percutaneous coronary intervention
stent implantation
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* ability to provide informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Death
timeFrame: 12 months
measure: Myocardial Infarction
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Target lesion revascularization
timeFrame: 12 months
measure: Unplanned hospitalization for unstable angina
timeFrame: 12 months
measure: Procedural and in-hospital complications
timeFrame: 30 days
measure: Bleeding events
timeFrame: 12 months
Other outcomes:
Locations:
city: Ascoli Piceno
country: Italy
facility: Division of Cardiology, Mazzoni Hospital
city: Catania
country: Italy
facility: Ferrarotto Hospital, University of Catania
city: Cirie
country: Italy
facility: Division of Cardiology, ASL TO4
city: Conegliano
country: Italy
facility: Division of Cardiology, Santa Maria dei Battuti Hospital
city: Legnano
country: Italy
facility: Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi
city: Milan
country: Italy
facility: Interventional Cardiology, Azienda Ospedaliera Fatebenefratelli
city: Napoli
country: Italy
facility: Division of Cardiology, Federico II University
city: Pietra Ligure
country: Italy
facility: Division of Cardiology, Santa Corona Hospital
city: Pisa
country: Italy
facility: Division of Cardiology, Fondazione Toscana G Monasterio
city: Roma
country: Italy
facility: Division of Cardiology, Policlinico Umberto I, La Sapienza University
city: Treviglio
country: Italy
facility: Division of Cardiology, ASST Bergamo Ovest
city: Turin
country: Italy
facility: AO Città della Salute e della Scienza
city: Selangor
country: Malaysia
facility: Cardiology Department, Manipal Klang Hospital
city: Katowice
country: Poland
facility: Division of Cardiology, Medical University of Silesia
Study officials:
affiliation: Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy
name: Claudio Moretti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Department of Medical Sciences, AO Città della Salute e della Scienza, University of Turin, Turin, Italy
name: Antonio Montefusco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Interventional Cardiology, A.O. Fatebenefratelli Milano, Italy
name: Bernardo Cortese, MD
role: PRINCIPAL_INVESTIGATOR
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