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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014