Optical Coherence Tomography for Drug Eluting Stent Safety

Study Overview
=================
Brief Summary
-----------------
Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively randomized to receive multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up

Detailed Description
-----------------
If overlapping drug-eluting stents provide increased vessel toxicity is not known. Given the association of delayed healing and incomplete endothelialization observed in animal and human autopsy studies at overlapping sites it is unclear why most patients do well with multiple DES implanted. OCT detecs smaller degrees of in-stent neointima more accurately than IVUS and might be a useful method for identify strut coverage and/or malapposition. Patients if eligible on the basis of clinical and angiographic criteria, are randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. Stent implantation are done accordingly to the normal interventional practice. QCA and IVUS are performed at the end of optimal stents placement per visual judgement (residual stenosis < 10%, TIMI 3 flow). Stent, lumen size and volume as well as complete stent strut apposal will be determined by IVUS analysis. Clinical follow-up will take place at 1 month (±1 week), 6 months (±2 weeks) and 1 year (±2 weeks). At 6-months follow-up all patients will undergo a quantitative coronary angiography (QCA), IVUS and Optical Coherence Tomography (LightLab OCT Imaging M2, automated pull back and flushing combination)assessments. OCT images will be acquired at 15-30 frames per second. Blind corelab quantitative strut by strut analysis will be performed using a novel dedicated software at each 0.5 mm section. The following OCT variables will be evaluated:number of visualized strut per section, mean-max neointimal thickness per section, % struts well apposed with neointima at overlapping vs non overlapping sites, % struts without neointima, % struts malapposed, rate of > 30% uncovered struts/total number of struts per section.

Official Title
-----------------
In-Vivo Vascular Response of Sirolimus-,Paclitaxel- and Zotarolimus-Eluting Stents in Long Lesions Requiring Overlapping. A Prospective, Randomized, Controlled Study Using Optical Coherence Tomography

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)
* Device: paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)
* Device: zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)
* Device: Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Native coronary artery disease with ≥ 75% diameter stenosis Lesion length ≥ 20 mm, Vessel size in between 2.5 and 3.5 mm. Multiple, overlapped DES vs BMS placement (intention to overlap ≥ 4 mm) Signed patient informed consent Exclusion Criteria: left main coronary artery disease, lesions in coronary artery bypass grafts, acute myocardial infarction, poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%. allergy to aspirin and or clopidogrel/ticlo, renal failure with creatinine value > 2.5, no suitable anatomy for OCT scan

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Device, Sirolimus drug-eluting stents implanted in overlap | Device: sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)<br>* comparison of multiple drug eluting stents<br>* Other names: Cypher™ (Cordis Corp, Johnson & Johnson Co) DES;|
| Active Comparator: 2<br>Device, paclitaxel polymer drug eluting stent | Device: paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)<br>* comparison of multiple drug eluting coronary stents<br>* Other names: Taxus Libertè™ (Boston Scientific, Natick MS) DES;|
| Active Comparator: 3<br>Device, zotarolimus drug eluting stent | Device: zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)<br>* comparison of multiple drug eluting coronary stents<br>* Other names: Endeavor™ (Medtronic, Santa Rosa, CA) DES;|
| Active Comparator: 4<br>bare metal coronary stents | Device: Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)<br>* comparison of DES in overlap vs BMS in overlap<br>* Other names: Libertè™ BMS(Boston Scientific, Natick, MS);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of uncovered and/or malapposed stent struts at overlapping versus non overlapping sites in drug eluting vs bare metal stents |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia Driven Target Vessel Failure |  | 12 months | 
| Number of uncovered and/or malapposed stent struts at overlapping sites in sirolimus-, paclitaxel- or zotarolimus eluting stents |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Percutaneous Coronary Interventions, Drug-Eluting stents, Optical Coherence Tomography, Thrombosis, Long lesions in native vessel requiring stents in overlap