Coronary Artery Disease
Conditions
Brief summary
The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.
Interventions
Single dose Sirolimus-Eluting coronary stent
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient must be minimum 18 years of age; 2. Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months; 3. 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-III) OR patients with documented silent ischemia; 4. Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion; 5. The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate); 6. The target lesion is \<30 mm in length (visual estimate) located in a native coronary artery; 7. Target lesion stenosis is \>50% and \<100% (TIMI I) (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 remains above normal at the time of treatment; 2. Patients admitted for treatment of diabetic ketoacidosis \> 2 times in the past six months (Brittle Diabetics); 3. Ejection fraction 30%; 4. Impaired renal function (creatinine \> 2.0 mg/dL);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure. | 6 months post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. | 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure |
| Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. | 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure |
| Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. | During Index Procedure |
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. | During Index Procedure |
| Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay. | During the hospital stay |
| Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. | 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure |
| In-stent and in-lesion mean percent diameter stenosis (%DS) and minimal lumen. diameter (MLD) measured by QCA post-procedure and at 6 months and 2 years. | post-procedure and at 6 months and 2 years |
| In-lesion late lumen loss measured by QCA at 6 months and 2 years. | 6 months and 2 years |
| Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years. | post-procedure 6 months and 2 years. |
| Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months. | baseline, 6, 12, and 24 months |
| C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes. | baseline, 6, 12, and 24 months |
| In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years. | 6 months and 2 years |
Countries
Brazil
Outcome results
None listed