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

Coronary Artery Disease Clinical Trial

— SCORPIUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00495898
• Other study ID #: CRDDE-001
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2007
• Last updated: December 2, 2009
• Start date: November 2002
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2009
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• CYPHER sirolimus-eluting stent
drug-eluting stent
• uncoated Bx VELOCITY balloon-expandable stent
bare metal stent

Locations

Country	Name	City	State
Germany	University of Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Baumgart D, Klauss V, Baer F, Hartmann F, Drexler H, Motz W, Klues H, Hofmann S, Völker W, Pfannebecker T, Stoll HP, Nickenig G; SCORPIUS Study Investigators. One-year results of the SCORPIUS study: a German multicenter investigation on the effectiveness — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	angiographic in-segment late loss		8 months post-procedure	Yes
Secondary	late loss		8 months post-procedure	Yes
Secondary	angiographic binary restenosis		8 months post-procedure	Yes
Secondary	target lesion revascularization (TLR)		8 months post-procedure	Yes
Secondary	target vessel revascularization (TVR)		8 months post-procedure	Yes
Secondary	target vessel failure (TVF)		8 months post-procedure	Yes
Secondary	procedure success		8 months post-procedure	No
Secondary	lesion success rate		0	Yes
Secondary	resource use		1 year post-procedure	No
Secondary	productivity loss		1 year post-procedure	No
Secondary	Major Adverse Cardiac Events (MACE)		30 days, and 8 and 12 months.	Yes