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.

Study Overview

• Status: Completed
• Conditions: Coronary Arteriosclerosis
• Intervention / Treatment: Device: Presillion stent

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

• Study Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• Portugal
  • Almada, Portugal, 2805-951
    • Hospital Garcia da Orta
  • Lisbon, Portugal, 2799-523
    • Hospital de Santa Cruz
  • Porto, Portugal, 4200-319
    • Hospital Sao Joao
  • Vila Real, Portugal, 5000 - 508
    • Centro Hospitalar Vila Real
• Spain
  • Albacete, Spain, 02006
    • Complejo Hospitalario Universitario de Albacete
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08022
    • Centro Médico Teknon
  • Lerida, Spain, 25198
    • Hospital Universitario Arnau de Vilanova
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
    • Sant Cugat del Valles, Barcelona, Spain, 08195
      • Capio Hospital General de Cataluña
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No specified

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))	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%).	at 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only	Peri-procedure up to discharge
Lesion Success	Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.	Peri-procedure up to discharge
Procedural Success	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	Peri-procedure up to discharge
Clinically Driven TLR	Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel	Up to 30 days
Clinically Driven TVR	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.	Up to 30 days
Target Vessel Failure	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: MI occurs in territory not clearly attributed to a vessel other than the target vessel.; Cardiac death not clearly due to a non-target vessel endpoint.; Target vessel revascularization is performed.	Up to 30 days
Myocardial Infarction	A positive diagnosis of myocardial infarction is made when one of the following criteria is met: Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:ischemic symptomsECG changes indicative of ischemia (ST segment elevation or depression)Development of pathological Q waves in the ECGImaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality; Pathological findings of an acute myocardial infarction	Up to 30 days
Major Bleeding		Up to 30 days
Stroke		Up to 30 days
Stent Thrombosis	Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.	Up to 30 days
Clinically Driven TLR	Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel	up to 12 months
Clinically Driven TVR	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.	Up to 12 months
Target Vessel Failure	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: MI occurs in territory not clearly attributed to a vessel other than the target vessel.; Cardiac death not clearly due to a non-target vessel endpoint.; Target vessel revascularization is performed.	Up to 12 months
Myocardial Infarction	A positive diagnosis of myocardial infarction is made when one of the following criteria is met: Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:ischemic symptomsECG changes indicative of ischemia (ST segment elevation or depression)Development of pathological Q waves in the ECGImaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality; Pathological findings of an acute myocardial infarction	Up to 12 months
Major Bleeding		Up to 12 months
Stent Thrombosis	Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.	Up to 12 months
Stroke		Up to 12 months

Collaborators and Investigators

• Sponsor: Johnson and Johnson, S.A.
• Investigators: Principal Investigator: Angel Cequier, MD, PhD, Hospital Universitario de Bellvitge

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (ESTIMATE): August 28, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2013
• Last Update Submitted That Met QC Criteria: March 5, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis
• Other Study ID Numbers: 08-CR-001