A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions (SCORPIUS)
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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 |
- angiographic in-segment late loss [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]
- 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 |
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 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 May 16, 2013