Coronary Disease
Conditions
Keywords
Percutaneous coronary intervention (PCI), Drug eluting stent (DES)
Brief summary
To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm and the dual pimecrolimus/paclitaxel-eluting (Symbio) coronary stent compared to the CoStar coronary stent control arm for the treatment of single de novo lesions \<25 mm in length in native coronary arteries 2.5 - 3.5 mm in diameter.
Detailed description
This study is designed to evaluate 6 month in-stent late lumen loss of the 1) Corio™ pimecrolimus-eluting coronary stent system and the 2) SymBio™ dual pimecrolimus/paclitaxel-eluting coronary stent system compared to the CoStar™ Paclitaxel-Eluting Coronary Stent System control arm.
Interventions
DEVICECorio™ Pimecrolimus-Eluting Coronary Stent System
Drug-eluting stent
DEVICESymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
Drug-eluting stent
DEVICECostar ™ Paclitaxel-Eluting Coronary Stent System
Drug-eluting Stent
Sponsors
Conor Medsystems
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Eligible for percutaneous coronary intervention (PCI). 2. Documented stable or unstable angina pectoris 3. Left ventricular ejection fraction (LVEF) ≥25% 4. Acceptable candidate for coronary artery bypass graft surgery (CABG). 5. Target lesion \< 25 mm in length with RVD of ≥2.5 mm to ≤3.5 mm with visually estimated stenosis of ≥50% and \< 100% . 6. Target vessel had not undergone prior revascularization within the preceding 6 months. 7. Target lesion must have been a minimum of 10 mm distance from any previously treated segment of the target vessel 8. Patient understood the study requirements and the treatment procedures and provided written Informed Consent, approved by the local Ethics Committee. 9. Willing to comply with all specified follow-up evaluations.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary angiographic late loss in the stent as measured by Quantitative Coronary Angiography (QCA) | 6 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE (composite of non-cardiac death, new Qw/nonQw MI, and TVR) as described below | 30 days and 6 months | Major Adverse Cardiac Events (MACE) defined as an adjudicated composite of death that cannot be clearly attributed to a non-cardiac event or non-intervention vessel, new myocardial infarction (Q-wave or non-Q-wave) that cannot be clearly attributed to a non-intervention vessel and clinically driven target vessel revascularization (TVR) |
| Primary Device Success defined as attainment of <50% in-stent residual stenosis of the target lesion using only the assigned device in the absence of device malfunction and device-related complication. | 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure | — |
| Lesion Success defined as attainment of <50% residual stenosis of the target lesion using the assigned study device or any percutaneous method. | 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure | — |
| Angiographic in-stent and in-segment binary restenosis (≥50% diameter stenosis). | 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure | — |
| In-stent and in-segment MLD | 6 months post-procedure | — |
| Procedure Success defined as attainment of final lesion success in the absence of in-hospital MACE. | 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure | — |
| Clinically driven Target Lesion Revascularization (TLR) | 6 months post-procedure | — |
| Percent volume obstruction of the stent by intravascular ultrasound (IVUS) in the IVUS cohort. | 6 months post-procedure | — |
| Incidence of late acquired incomplete stent to vessel apposition (stent malapposition) by IVUS in the IVUS cohort. | 6 months post-procedure | — |
| Incidence of reported MACE | 1, 2, 3, 4 and 5 years post-procedure | — |
| Comparison of the pimecrolimus-eluting stent to the pimecrolimus/paclitaxel-eluting stent for primary and secondary endpoints. | 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure | — |
| In-segment angiographic late loss | 6 months post-procedure | — |
Countries
United Kingdom
Outcome results
None listed