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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00495898
First received: July 2, 2007
Last updated: December 2, 2009
Last verified: December 2009
  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 4

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

Resource links provided by NLM:


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
Study Completion Date: November 2009
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 Universität Duisburg-Essen
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hans-Peter Stoll, Cordis
ClinicalTrials.gov Identifier: NCT00495898     History of Changes
Other Study ID Numbers: CRDDE-001
Study First Received: July 2, 2007
Last Updated: December 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014