Coronary Arteriosclerosis
Conditions
Brief summary
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
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
Interventions
DEVICEPresillion stent
Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).
Sponsors
Johnson and Johnson, S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All subjects treated with Presillion stent up to two de novo coronary artery lesions
Exclusion criteria
* No specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)) | at 12 months follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Lesion Success | Peri-procedure up to discharge | Lesion success defined as the attainment of \<50% final diameter stenosis (by visual estimate) using any percutaneous method. |
| Procedural Success | Peri-procedure up to discharge | 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 | Up to 30 days | 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 | Up to 30 days | 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. |
| Device Success | Peri-procedure up to discharge | Device success defined as achievement of a final diameter stenosis of \<50% (by visual estimate), using the assigned device only |
| Myocardial Infarction | Up to 30 days | 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 | Up to 30 days | — |
| Stroke | Up to 30 days | — |
| Stent Thrombosis | Up to 30 days | Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel. |
| Target Vessel Failure | Up to 30 days | 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. |
Countries
Portugal, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treated With Presillion Stent Patients treated with the Presillion stent in up to two de novo coronary artery lesions | 318 |
| Total | 318 |
Baseline characteristics
| Characteristic | Treated With Presillion Stent |
|---|---|
| Age Continuous | 65.5 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment Portugal | 56 participants |
| Region of Enrollment Spain | 262 participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 248 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 318 |
| serious Total, serious adverse events | 39 / 318 |
Outcome results
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%).
Time frame: at 12 months follow-up
Population: No formal statistical significance testing was performed. Descriptive statistics were calculated for all relevant variables (mean, standard deviation, median and ranges for the continuous variables and with frequencies and % for the discrete variables). Subjects who discontinued prematurely were included in the analysis and were not replaced.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)) | 9 participants |
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
Time frame: up to 12 months
Population: 303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Clinically Driven TLR | 5 participants |
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
Time frame: Up to 30 days
Population: 309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Clinically Driven TLR | 2 participants |
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.
Time frame: Up to 30 days
Population: 309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Clinically Driven TVR | 2 participants |
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.
Time frame: Up to 12 months
Population: 303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Clinically Driven TVR | 5 participants |
Secondary
Device Success
Device success defined as achievement of a final diameter stenosis of \<50% (by visual estimate), using the assigned device only
Time frame: Peri-procedure up to discharge
Population: 318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Device Success | 98.9 percentage of device success |
Secondary
Lesion Success
Lesion success defined as the attainment of \<50% final diameter stenosis (by visual estimate) using any percutaneous method.
Time frame: Peri-procedure up to discharge
Population: 318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Lesion Success | 98.6 percentage of lesion Success |
Secondary
Major Bleeding
Time frame: Up to 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Major Bleeding | 0 participants |
Secondary
Major Bleeding
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Major Bleeding | 0 participants |
Secondary
Myocardial Infarction
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
Time frame: Up to 12 months
Population: 303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Myocardial Infarction | 8 participants |
Secondary
Myocardial Infarction
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
Time frame: Up to 30 days
Population: 309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Myocardial Infarction | 6 participants |
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
Time frame: Peri-procedure up to discharge
Population: 318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Procedural Success | 97.2 percentage of Procedural Success |
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.
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Stent Thrombosis | 2 participants |
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.
Time frame: Up to 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Stent Thrombosis | 2 participants |
Secondary
Stroke
Time frame: Up to 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Stroke | 0 participants |
Secondary
Stroke
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Stroke | 0 participants |
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: 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.
Time frame: Up to 12 months
Population: 303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Target Vessel Failure | 11 participants |
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: 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.
Time frame: Up to 30 days
Population: 309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Presillion Stent | Target Vessel Failure | 7 participants |