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
1 other identifier
observational
318
2 countries
13
Brief Summary
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 27, 2009
CompletedFirst Posted
Study publicly available on registry
August 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
March 6, 2013
CompletedMarch 13, 2013
March 1, 2013
2 years
August 27, 2009
January 15, 2013
March 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Device Success
Peri-procedure up to discharge
Lesion Success
Peri-procedure up to discharge
Procedural Success
Peri-procedure up to discharge
Clinically Driven TLR
Up to 30 days
Clinically Driven TVR
Up to 30 days
- +12 more secondary outcomes
Study Arms (1)
Presillion stent
Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Interventions
Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).
Eligibility Criteria
All sujects treated with Presillion stent up to two de novo coronary artery lesions
You may qualify if:
- All subjects treated with Presillion stent up to two de novo coronary artery lesions
You may not qualify if:
- No specified
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Hospital Garcia Da Orta
Almada, 2805-951, Portugal
Hospital de Santa Cruz
Lisbon, 2799-523, Portugal
Hospital Sao Joao
Porto, 4200-319, Portugal
Centro Hospitalar Vila Real
Vila Real, 5000 - 508, Portugal
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, 02006, Spain
Hospital Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Centro Medico Teknon
Barcelona, Barcelona, 08022, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Capio Hospital General de Cataluña
Sant Cugat del Vallès, Barcelona, 08195, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Arnau de Vilanova
Lleida, Lerida, 25198, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
since the difference with the performance goal is this large; the possibility of underreporting of adverse events is something that needs to be considered.
Results Point of Contact
- Title
- Mayda Lopez-Belmonte, PhD
- Organization
- Johnson and Johnson Medical Iberia
Study Officials
- PRINCIPAL INVESTIGATOR
Angel Cequier, MD, PhD
Hospital Universitario de Bellvitge
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2009
First Posted
August 28, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2011
Study Completion
May 1, 2011
Last Updated
March 13, 2013
Results First Posted
March 6, 2013
Record last verified: 2013-03