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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00235066
First received: October 6, 2005
Last updated: September 15, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Device: PCI
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • In-lesion late lumen loss [ Time Frame: 8-moths post-procedure ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: November 2002
Study Completion Date: April 2006
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cypher Sirolimus-Eluting Stent
 Device: PCI
PCI with Cypher Sirolimus-Eluting Stent
Other Name: drug-eluting 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235066

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

Publications:

Responsible Party: Dr. Hans-Peter Stoll, MD, Cordis
ClinicalTrials.gov Identifier: NCT00235066     History of Changes
Other Study ID Numbers: EC02-04
Study First Received: October 6, 2005
Last Updated: September 15, 2008
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013