The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions. (SVELTE)
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|ClinicalTrials.gov Identifier: NCT00235066|
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : September 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: PCI||Phase 4|
This is an international, multicenter (up to 10 sites), nonrandomized, historically controlled study in patients with De Novo coronary artery lesions in small vessels treated with the CYPHER™ (sirolimus-eluting) stent as compared to the small vessel tercile uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial. A total of up to 100 patients will be enrolled in this study.
Patients with de novo native coronary artery lesions >=15mm and <=30mm in length and >=2.25 mm to <=2.75 mm in diameter by visual estimation will be treated with the CYPHER™ (sirolimus-eluting) stent. Patients will be followed at 30 days, 6, 8, 9 months and at 1, 2 and 3 years post-procedure, with a repeat angiography at 8 months. In all patients Intravascular Ultrasound (IVUS) will be performed before (only in case of crossing success) and after the initial procedure. An IVUS control will also be done at 8 months follow up to assess neo-intimal growth and remodeling.
This is a single lesion treatment study. Patients may have other lesions treated before the treatment of the intended lesion in the small vessel (a non-target lesion may not be located in the target vessel!). Post-procedural treatment of another lesion is only allowed after the 30-day follow-up contact has been completed or in case this is clinically needed.
It is anticipated that the total length of the study will be 39 months: 3 months to complete patient enrollment and 3 years for follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Nonrandomized, Historical Controlled Study In Patients With De Novo Coronary Artery Lesions In Small VessELs Treated With The CYPHER™ STEnt|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||November 2003|
|Actual Study Completion Date :||April 2006|
Cypher Sirolimus-Eluting Stent
PCI with Cypher Sirolimus-Eluting Stent
Other Name: drug-eluting stent
- In-lesion late lumen loss [ Time Frame: 8-moths post-procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235066
|University Hospital, Swiss Cardiovascular CenterBern|
|Bern, Switzerland, 3010|
|Principal Investigator:||Bernhard Meier, MD||University of Bern|