NCT00495898

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 3, 2009

Status Verified

December 1, 2009

Enrollment Period

2.5 years

First QC Date

July 2, 2007

Last Update Submit

December 2, 2009

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • angiographic in-segment late loss

    8 months post-procedure

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

CYPHER sirolimus-eluting stent

Device: CYPHER sirolimus-eluting stent

2

ACTIVE COMPARATOR

uncoated Bx VELOCITY balloon-expandable stent

Device: uncoated Bx VELOCITY balloon-expandable stent

Interventions

CYPHER sirolimus-eluting stentDEVICE

drug-eluting stent

1
uncoated Bx VELOCITY balloon-expandable stentDEVICE

bare metal stent

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Essen

Essen, 45147, Germany

Location

Related Publications (2)

  • 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.

    PMID: 17950142RESULT

  • 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.

    PMID: 22424016DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dietrich Baumgart, MD, PhD

    Universität Duisburg-Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 3, 2007

Study Start

November 1, 2002

Primary Completion

May 1, 2005

Study Completion

November 1, 2009

Last Updated

December 3, 2009

Record last verified: 2009-12

Locations

DE(1)