Self-apposing Stentys Stents Registry (SPARTA)

December 16, 2016 updated by: Claudio Moretti, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Safety and Effectiveness of the Self-aPposing, bAlloon-delivered, dRug-eluting Stent for the Treatment of the Coronary Artery Disease: A multiCenter Registry

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.

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ascoli Piceno, Italy
        • Recruiting
        • Division of Cardiology, Mazzoni Hospital
        • Contact:
          • Luciano Moretti, MD
        • Contact:
          • Simona Silenzi, MD
        • Sub-Investigator:
          • Pierfrancesco Grossi, MD
      • Catania, Italy
        • Recruiting
        • Ferrarotto Hospital, University of Catania
        • Contact:
          • Alessio La Manna, MD
      • Cirie, Italy
        • Recruiting
        • Division of Cardiology, ASL TO4
        • Contact:
          • Pietro Gaetano, MD
      • Conegliano, Italy
        • Recruiting
        • Division of Cardiology, Santa Maria dei Battuti Hospital
        • Contact:
          • Andrea Pavei, MD
      • Legnano, Italy
        • Recruiting
        • Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi
        • Contact:
          • Arnaldo Poli, MD
      • Milan, Italy
        • Recruiting
        • Interventional Cardiology, Azienda Ospedaliera Fatebenefratelli
        • Contact:
          • Bernardo Cortese, MD
      • Napoli, Italy
        • Recruiting
        • Division of Cardiology, Federico II University
        • Contact:
          • Giovanni Esposito, MD, Prof
        • Contact:
          • Plinio Cirillo, MD, Prof
      • Pietra Ligure, Italy
        • Recruiting
        • Division of Cardiology, Santa Corona Hospital
        • Contact:
          • Anna Maria Nicolino, MD
      • Pisa, Italy
        • Recruiting
        • Division of Cardiology, Fondazione Toscana G Monasterio
        • Contact:
          • Luigi Emilio Pastormerlo, MD
        • Contact:
          • Cataldo Palmieri, MD
      • Roma, Italy
        • Recruiting
        • Division of Cardiology, Policlinico Umberto I, La Sapienza University
        • Contact:
          • Gennaro Sardella, MD
        • Contact:
          • Massimo Mancone, MD
        • Principal Investigator:
          • Massimo Mancone, MD
        • Sub-Investigator:
          • Simone Calcagno, MD
      • Treviglio, Italy
        • Recruiting
        • Division of Cardiology, ASST Bergamo Ovest
        • Contact:
          • Paolo Sganzerla, MD
      • Turin, Italy, 10126
        • Recruiting
        • AO Città della Salute e della Scienza
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudio Moretti, MD
        • Principal Investigator:
          • Antonio Montefusco, MD
        • Sub-Investigator:
          • Sebastiano Gili, MD
  • Malaysia
      • Selangor, Malaysia
        • Recruiting
        • Cardiology Department, Manipal Klang Hospital
        • Contact:
          • Kuan Leong Yew, MD, Prof
  • Poland
      • Katowice, Poland
        • Recruiting
        • Division of Cardiology, Medical University of Silesia
        • Contact:
          • Grzegorz Smolka, MD, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • ≥ 18 years old
  • ability to provide informed consent

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events (MACE)
Time Frame: 12 months
A composite end-point of death, myocardial infarction, stent thrombosis, unplanned hospitalization for unstable angina, target lesion revascularization
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 12 months
12 months
Myocardial Infarction
Time Frame: 12 months
Incident rate of myocardial infarction
12 months
Stent thrombosis
Time Frame: 12 months
Incident rate of stent thrombosis
12 months
Target lesion revascularization
Time Frame: 12 months
Incident rate of target lesion revascularization
12 months
Unplanned hospitalization for unstable angina
Time Frame: 12 months
Incident rate of unplanned hospitalization for unstable angina
12 months
Procedural and in-hospital complications
Time Frame: 30 days
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
Bleeding events
Time Frame: 12 months
Incident rate of bleedings classified according to the BARC criteria
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sparta2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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