MedDataX Logo

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

NCT ID: NCT00495898

Last Updated: 2009-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

CYPHER sirolimus-eluting stent

Group Type EXPERIMENTAL

CYPHER sirolimus-eluting stent

Intervention Type DEVICE

drug-eluting stent

2

uncoated Bx VELOCITY balloon-expandable stent

Group Type ACTIVE_COMPARATOR

uncoated Bx VELOCITY balloon-expandable stent

Intervention Type DEVICE

bare metal stent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CYPHER sirolimus-eluting stent

drug-eluting stent

Intervention Type DEVICE

uncoated Bx VELOCITY balloon-expandable stent

bare metal stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cordis Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cordis

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dietrich Baumgart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universität Duisburg-Essen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Essen

Essen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17950142 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22424016 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRDDE-001

Identifier Type: -

Identifier Source: org_study_id