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The objective of this study is to compare the safety and effectiveness of two different approaches to treat bifurcational lesions with CYPHER SELECTâ„¢ Sirolimus-eluting Balloon-expandable Coronary Stent , Cordis Corp): a) the "crushing" technique to stent both branches vs. b) a provisional T stenting technique of the side branch.
This is a prospective, randomized study that will be conducted at up to 5 centers in Italy. All patients who meet the eligibility criteria will be treated with the Cypher SelectTM Stent and Stent Delivery System (SDS). Patients will have repeat angiography at six months, with clinical follow-up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | crushing technique |
|
| 2 | Active Comparator | provisional T stenting technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SES | Device | CYPHER SELECTâ„¢ Sirolimus-eluting Balloon-expandable Coronary Stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse and Cardiac Events (MACE) | 6 and 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal lumen diameter (MLD) | 6 months | |
| Percent diameter stenosis (%DS) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Colombo, MD, PhD | Fondazione Centro San Raffaele del Monte Tabor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Centro San Raffaele del Monte Tabor | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19103990 | Result | Colombo A, Bramucci E, Sacca S, Violini R, Lettieri C, Zanini R, Sheiban I, Paloscia L, Grube E, Schofer J, Bolognese L, Orlandi M, Niccoli G, Latib A, Airoldi F. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study. Circulation. 2009 Jan 6;119(1):71-8. doi: 10.1161/CIRCULATIONAHA.108.808402. Epub 2008 Dec 22. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| SES |
| Device |
CYPHER SELECTâ„¢ Sirolimus-eluting Balloon-expandable Coronary Stent |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |