A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions

Cordis US Corp.200 enrolled

Overview

The main objective of this study is to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.

This is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Patients with de novo native coronary artery lesions \<= 42 mm in length and \>=2.5mm and \<=3.5mm in diameter (by visual estimate) will be included in the study. A total of 190 patients will be entered and randomly allocated to the CYPHERTM sirolimus-eluting stent or the uncoated Bx VELOCITY balloon-expandable stent at a 1:1 ratio. Patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month). It is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for follow up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Coronary Artery Disease

Interventions

CYPHER sirolimus-eluting stentDEVICE

drug-eluting stent

uncoated Bx VELOCITY balloon-expandable stentDEVICE

bare metal stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia; * Manifest diabetes mellitus, proven by fasting glucose (12 h) \> 127 mg/dl or oral glucose challenge: \>= 200 mg/dl after 2 h or diabetes mellitus already treated with oral antidiabetics or insulin; * Treatment of a de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with 2- or more-vessel-disease can be enrolled if previous treatment(s) of those lesions other than the target lesion have taken place at least 3 months prior to the enrolment to this study. If more than 1 study stent is necessary to treat the lesion, overlapping is strongly recommended; * Target vessel diameter at the lesion site is \>= 2.5mm and \<= 3.5mm (visual estimate); (stents will be available in 2.5 / 3.0 mm width); * Target lesion is \<= 42mm in length (visual estimate); (stents will be available in 8, 18 and 33 mm length); * Target lesion diameter stenosis is \> 50% and \<100% (visual estimate); Exclusion Criteria: None

Locations (1)

University of Essen

Essen, Germany