search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
PCI
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; 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. Target vessel diameter >=2.25 and <=2.75mm (by visual estimation); Target lesion length >=15 and <=30 mm. Exclusion Criteria: 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; Has unstable angina classified as Braunwald A (1, 2, 3) or B & C 3; Unprotected left main coronary disease with >=50% stenosis; Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff; Have an ostial target lesion; Lesion < 2.25 or > 2.75 mm in diameter; Totally occluded vessel (TIMI 0 level); Documented left ventricular ejection fraction £30%; Intention to treat the target lesion by direct stenting procedure.

Sites / Locations

  • University Hospital, Swiss Cardiovascular CenterBern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Cypher Sirolimus-Eluting Stent

Outcomes

Primary Outcome Measures

In-lesion late lumen loss

Secondary Outcome Measures

Full Information

First Posted
October 6, 2005
Last Updated
September 15, 2008
Sponsor
Cordis Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00235066
Brief Title
The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions.
Acronym
SVELTE
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cypher Sirolimus-Eluting Stent
Intervention Type
Device
Intervention Name(s)
PCI
Other Intervention Name(s)
drug-eluting stent
Intervention Description
PCI with Cypher Sirolimus-Eluting Stent
Primary Outcome Measure Information:
Title
In-lesion late lumen loss
Time Frame
8-moths post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Target vessel diameter >=2.25 and <=2.75mm (by visual estimation); Target lesion length >=15 and <=30 mm. Exclusion Criteria: 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; Has unstable angina classified as Braunwald A (1, 2, 3) or B & C 3; Unprotected left main coronary disease with >=50% stenosis; Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff; Have an ostial target lesion; Lesion < 2.25 or > 2.75 mm in diameter; Totally occluded vessel (TIMI 0 level); Documented left ventricular ejection fraction £30%; Intention to treat the target lesion by direct stenting procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Meier, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Swiss Cardiovascular CenterBern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16644326
Citation
Meier B, Sousa E, Guagliumi G, Van den Branden F, Grenadier E, Windecker S, te Riele H, Voudris V, Eltchaninoff H, Lindvall B, Snead D, Talen A; SVELTE Study Group. Sirolimus-eluting coronary stents in small vessels. Am Heart J. 2006 May;151(5):1019.e1-7. doi: 10.1016/j.ahj.2006.02.025.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs