Coronary Artery Disease
Conditions
Brief summary
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
Interventions
DEVICECYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Sponsors
Cordis US Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant female patients 18 years of age 2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia; 3. Treatment of a single de novo target lesion in a major native coronary artery; 4. Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate); 5. Target lesion is 30mm in length (visual estimate); 6. Target lesion stenosis is \> 50% and \< 100% (visual estimate);
Exclusion criteria
1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \> 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment; 2. Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina; 3. Significant (\> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; 4. Documented Left ventricular ejection fraction 25%; 5. Totally occluded vessel (TIMI 0 level); 6. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge | From post-procedure up to hospital discharge | Procedure Success is defined as the final residual diameter stenosis \< 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later | From post-procedure up to 30 days | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). |
| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge | From post-procedure up to hospital discharge | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). |
| Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later | From post-procedure up to 12 months | Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR). |
Countries
United States
Participant flow
Recruitment details
First patient enrolled was Apr 2004 and last patient enrolled was Jul 2004.
Participants by arm
| Arm | Count |
|---|---|
| CYPHER NxT Stent on the BX SONIC OTW SDS CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | CYPHER NxT Stent on the BX SONIC OTW SDS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 51 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants |
| Age Continuous | 64.39 years STANDARD_DEVIATION 10.8 |
| Patients with Diabetes Mellitus With Diabetes Mellitus | 25 participants |
| Patients with Diabetes Mellitus Without Diabetes Mellitus | 75 participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 96 |
| serious Total, serious adverse events | 1 / 95 |
Outcome results
Primary
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
Procedure Success is defined as the final residual diameter stenosis \< 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion
Time frame: From post-procedure up to hospital discharge
Population: Patients who were followed up to hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYPHER NxT Stent on the BX SONIC OTW SDS | Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge | 97 Percentage of Participants |
95% CI: [91.5, 99.4]Qualitative Comparison
Secondary
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Time frame: From post-procedure up to 12 months
Population: Patients who had at least 330 days clinical follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYPHER NxT Stent on the BX SONIC OTW SDS | Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later | 10.4 Percentage of participants |
95% CI: [5.1, 18.3]Descriptive statistics
Secondary
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Time frame: From post-procedure up to 30 days
Population: Patients who had 30 days clinical follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYPHER NxT Stent on the BX SONIC OTW SDS | Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later | 3.0 Percentage of Participants |
95% CI: [0.6, 8.6]No formal statistical testing
Secondary
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Time frame: From post-procedure up to hospital discharge
Population: Patients who were followed up to hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYPHER NxT Stent on the BX SONIC OTW SDS | Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge | 3.0 Percentage of participants |
95% CI: [0.6, 8.5]Descriptive statistics