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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: CYPHER sirolimus-eluting stent; Device: uncoated Bx VELOCITY balloon-expandable 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45147
    • University of Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; CYPHER sirolimus-eluting stent	Device: CYPHER sirolimus-eluting stent; drug-eluting stent
Active Comparator: 2; uncoated Bx VELOCITY balloon-expandable stent	Device: uncoated Bx VELOCITY balloon-expandable stent; bare metal stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
angiographic in-segment late loss	8 months post-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
late loss	8 months post-procedure
angiographic binary restenosis	8 months post-procedure
target lesion revascularization (TLR)	8 months post-procedure
target vessel revascularization (TVR)	8 months post-procedure
target vessel failure (TVF)	8 months post-procedure
procedure success	8 months post-procedure
lesion success rate
resource use	1 year post-procedure
productivity loss	1 year post-procedure
Major Adverse Cardiac Events (MACE)	30 days, and 8 and 12 months.

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Dietrich Baumgart, MD, PhD, Universität Duisburg-Essen

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.jacc.2007.07.035.
• Sinning JM, Baumgart D, Werner N, Klauss V, Baer FM, Hartmann F, Drexler H, Motz W, Klues H, Voelker W, Pfannebecker T, Stoll HP, Nickenig G; SCORPIUS Study. Five-year results of the 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 (SCORPIUS) study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients. Am Heart J. 2012 Mar;163(3):446-53, 453.e1. doi: 10.1016/j.ahj.2011.12.010.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: July 2, 2007
• First Submitted That Met QC Criteria: July 2, 2007
• First Posted (Estimate): July 3, 2007

Study Record Updates

• Last Update Posted (Estimate): December 3, 2009
• Last Update Submitted That Met QC Criteria: December 2, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: CRDDE-001