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

August 27, 2009
March 5, 2013
April 2009
April 2011   (final data collection date for primary outcome measure)
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%).

Major Cardiac Adverse Events (including cardiac death, imyocardial 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 ]
Complete list of historical versions of study NCT00968019 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
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

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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Coronary Arteriosclerosis
Device: Presillion stent
Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).
Presillion stent
Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Intervention: Device: Presillion stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
May 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • No specified
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Portugal,   Spain
 
NCT00968019
08-CR-001
Yes
Johnson and Johnson, S.A.
Johnson and Johnson, S.A.
Not Provided
Principal Investigator: Angel Cequier, MD, PhD Hospital Universitario de Bellvitge
Johnson and Johnson, S.A.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP