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

NCT00235066 | Completed Phase 4 DMC

• 1 other identifier: EC02-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-lesion late lumen loss

  8-moths post-procedure

Study Arms (1)

1

EXPERIMENTAL

Cypher Sirolimus-Eluting Stent

Device: PCI

Interventions

PCI DEVICE

PCI with Cypher Sirolimus-Eluting Stent

Also known as: drug-eluting stent

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

University Hospital, Swiss Cardiovascular CenterBern

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 16644326 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Bernhard Meier, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: November 1, 2002
• Primary Completion: November 1, 2003
• Study Completion: April 1, 2006
• Last Updated: September 16, 2008

Record last verified: 2008-09

Locations

CH (1)