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

Coronary Arteriosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968019
• Other study ID #: 08-CR-001
• Status: Completed
• Phase: N/A
• First received: August 27, 2009
• Last updated: March 5, 2013
• Start date: April 2009
• Est. completion date: May 2011

Study information

• Verified date: March 2013
• Source: Johnson and Johnson, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteePortugal: Ethics Committee for Clinical Research
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No specified

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• Presillion stent
Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).

Locations

Country	Name	City	State
Portugal	Hospital Garcia Da Orta	Almada
Portugal	Hospital de Santa Cruz	Lisbon
Portugal	Hospital Sao Joao	Porto
Portugal	Centro Hospitalar Vila Real	Vila Real
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital Germans Trias I Pujol	Badalona	Barcelona
Spain	Centro Medico Teknon	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Arnau de Vilanova	Lerida
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Capio Hospital General de Cataluña	Sant Cugat del Valles	Barcelona
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Johnson and Johnson, S.A.

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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 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; Pathological findings of an acute myocardial infarction	Up to 30 days	Yes
Secondary	Major Bleeding		Up to 30 days	Yes
Secondary	Stroke		Up to 30 days	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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 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; Pathological findings of an acute myocardial infarction	Up to 12 months	Yes
Secondary	Major Bleeding		Up to 12 months	Yes
Secondary	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	Yes
Secondary	Stroke		Up to 12 months	Yes