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The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions. (SVELTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235066
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : September 16, 2008
Information provided by:
Cordis Corporation

Brief Summary:
The main objective of this study is to assess the effectiveness of the CYPHER™ (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessels (2.25 - 2.75 mm) as compared to the small vessel tercile of the uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial, using a stenting technique that minimizes balloon trauma to the vessel and assures full coverage of the lesion with the stent.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: PCI Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: 1
Cypher Sirolimus-Eluting Stent
Device: PCI
PCI with Cypher Sirolimus-Eluting Stent
Other Name: drug-eluting stent

Primary Outcome Measures :
  1. In-lesion late lumen loss [ Time Frame: 8-moths post-procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS 1, 2, 3, 4) OR unstable angina pectoris (Braunwald Classification B&C 1-2) OR patients with documented silent ischemia;
  2. Single treatment of de novo lesion in a small vessel (2.25 - 2.75 mm) in a major coronary artery in patients with single or multivessel disease. Patients with multiple lesions can be included if the other lesions are successfully treated prior to the treatment of the intended lesion in the small vessel.
  3. Target vessel diameter >=2.25 and <=2.75mm (by visual estimation);
  4. Target lesion length >=15 and <=30 mm.

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 or the CK and CK-MB remains above normal at the time of the treatment;
  2. Has unstable angina classified as Braunwald A (1, 2, 3) or B & C 3;
  3. Unprotected left main coronary disease with >=50% stenosis;
  4. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
  5. Have an ostial target lesion;
  6. Lesion < 2.25 or > 2.75 mm in diameter;
  7. Totally occluded vessel (TIMI 0 level);
  8. Documented left ventricular ejection fraction £30%;
  9. Intention to treat the target lesion by direct stenting procedure.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00235066

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University Hospital, Swiss Cardiovascular CenterBern
Bern, Switzerland, 3010
Sponsors and Collaborators
Cordis Corporation
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Principal Investigator: Bernhard Meier, MD University of Bern

Publications of Results:
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Responsible Party: Dr. Hans-Peter Stoll, MD, Cordis Identifier: NCT00235066     History of Changes
Other Study ID Numbers: EC02-04
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: September 16, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases