A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00495898

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: CYPHER sirolimus-eluting stent Device: uncoated Bx VELOCITY balloon-expandable stent	Phase IV

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A German Multicenter, Randomized, Controlled, Open-Label Study of the Cypher Sirolimus-Eluting Stent in the Treatment of Diabetic Patients With De Novo Native Coronary Artery Lesions

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

angiographic in-segment late loss [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

late loss [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]
angiographic binary restenosis [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]
target lesion revascularization (TLR) [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]
target vessel revascularization (TVR) [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]
target vessel failure (TVF) [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]
procedure success [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: No ]
lesion success rate [ Time Frame: 0 ] [ Designated as safety issue: Yes ]
resource use [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: No ]
productivity loss [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: No ]
Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days, and 8 and 12 months. ] [ Designated as safety issue: Yes ]

Enrollment:	200
Study Start Date:	November 2002
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CYPHER sirolimus-eluting stent	Device: CYPHER sirolimus-eluting stent drug-eluting stent
2: Active Comparator uncoated Bx VELOCITY balloon-expandable stent	Device: uncoated Bx VELOCITY balloon-expandable stent bare metal stent

Detailed Description:

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495898

Locations

Germany
University of Essen
Essen, Germany, 45147

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

Dietrich Baumgart, MD, PhD

Univeristat Duisburg-Essen

More Information

Publications of Results:

Baumgart D, Klauss V, Baer F, Hartmann F, Drexler H, Motz W, Klues H, Hofmann S, Volker W, Pfannebecker T, Stoll HP, Nickenig G; SCORPIUS Study Investigators. One-year results of the SCORPIUS study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients. J Am Coll Cardiol. 2007 Oct 23;50(17):1627-34.

Responsible Party:	Cordis ( Dr. Hans-Peter Stoll )
Study ID Numbers:	CRDDE-001
Study First Received:	July 2, 2007
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00495898
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clotrimazole
Miconazole

Myocardial Ischemia
Tioconazole
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009