Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson and Johnson, S.A.
ClinicalTrials.gov Identifier:
NCT00968019
First received: August 27, 2009
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.


Condition Intervention
Coronary Arteriosclerosis
Device: Presillion stent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Postmarket Surveillance Registry Evaluating the Performance and Long Term Safety of the Presillion Stent in de Novo Native Coronary Artery Lesions. Iberian Registry

Resource links provided by NLM:


Further study details as provided by Johnson and Johnson, S.A.:

Primary Outcome Measures:
  • Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)) [ Time Frame: at 12 months follow-up ] [ Designated as safety issue: Yes ]

    Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR).

    The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%).



Secondary Outcome Measures:
  • Device Success [ Time Frame: Peri-procedure up to discharge ] [ Designated as safety issue: Yes ]
    Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only

  • Lesion Success [ Time Frame: Peri-procedure up to discharge ] [ Designated as safety issue: Yes ]
    Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.

  • Procedural Success [ Time Frame: Peri-procedure up to discharge ] [ Designated as safety issue: Yes ]
    Procedural success defined as achievement of a final diameter stenosis of <50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay

  • Clinically Driven TLR [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel

  • Clinically Driven TVR [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.

  • Target Vessel Failure [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]

    Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.

    Target vessel failure will be reported when:

    1. MI occurs in territory not clearly attributed to a vessel other than the target vessel.
    2. Cardiac death not clearly due to a non-target vessel endpoint.
    3. Target vessel revascularization is performed.

  • Myocardial Infarction [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]

    A positive diagnosis of myocardial infarction is made when one of the following criteria is met:

    1. Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:

      • ischemic symptoms
      • ECG changes indicative of ischemia (ST segment elevation or depression)
      • Development of pathological Q waves in the ECG
      • Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality
    2. Pathological findings of an acute myocardial infarction

  • Major Bleeding [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.

  • Clinically Driven TLR [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel

  • Clinically Driven TVR [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.

  • Target Vessel Failure [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

    Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.

    Target vessel failure will be reported when:

    1. MI occurs in territory not clearly attributed to a vessel other than the target vessel.
    2. Cardiac death not clearly due to a non-target vessel endpoint.
    3. Target vessel revascularization is performed.

  • Myocardial Infarction [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

    A positive diagnosis of myocardial infarction is made when one of the following criteria is met:

    1. Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:

      • ischemic symptoms
      • ECG changes indicative of ischemia (ST segment elevation or depression)
      • Development of pathological Q waves in the ECG
      • Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality
    2. Pathological findings of an acute myocardial infarction

  • Major Bleeding [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.

  • Stroke [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 318
Study Start Date: April 2009
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Presillion stent
Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Device: Presillion stent
Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).

Detailed Description:

Primary endpoint: Composite of Major Adverse Cardiac Events (MACE), which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR) at 12 months follow-up.

Data will be collected on 400 patients (from 14 hospitals in Spain and Portugal) treated with the Presillion stent in up to 2 de novo native coronary artery lesions

Study design: multicenter, prospective, observational

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All sujects treated with Presillion stent up to two de novo coronary artery lesions

Criteria

Inclusion Criteria:

  • All subjects treated with Presillion stent up to two de novo coronary artery lesions

Exclusion Criteria:

  • No specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968019

Locations
Portugal
Hospital Garcia Da Orta
Almada, Portugal, 2805-951
Hospital de Santa Cruz
Lisbon, Portugal, 2799-523
Hospital Sao Joao
Porto, Portugal, 4200-319
Centro Hospitalar Vila Real
Vila Real, Portugal, 5000 - 508
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Capio Hospital General de Cataluña
Sant Cugat del Valles, Barcelona, Spain, 08195
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Complejo Hospitalario Universitario de Albacete
Albacete, Spain, 02006
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Centro Medico Teknon
Barcelona, Spain, 08022
Hospital Universitario Arnau de Vilanova
Lerida, Spain, 25198
Sponsors and Collaborators
Johnson and Johnson, S.A.
Investigators
Principal Investigator: Angel Cequier, MD, PhD Hospital Universitario de Bellvitge
  More Information

No publications provided

Responsible Party: Johnson and Johnson, S.A.
ClinicalTrials.gov Identifier: NCT00968019     History of Changes
Other Study ID Numbers: 08-CR-001
Study First Received: August 27, 2009
Results First Received: January 15, 2013
Last Updated: March 5, 2013
Health Authority: Spain: Ethics Committee
Portugal: Ethics Committee for Clinical Research

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on April 22, 2014