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Coronary Artery DiseasePhase 4SCORPIUSNCT00495898

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

A Phase 4 study testing CYPHER sirolimus-eluting stent and uncoated Bx VELOCITY balloon-expandable stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
CYPHER sirolimus-eluting stent and uncoated Bx VELOCITY balloon-expandable stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteGermany
Study dates
Nov 2002to Nov 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Essen

    Essen, 45147

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
CYPHER sirolimus-eluting stent, uncoated Bx VELOCITY balloon-expandable stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CYPHER sirolimus-eluting stentDevice

    drug-eluting stent

  • uncoated Bx VELOCITY balloon-expandable stentDevice

    bare metal stent

Study groups in NCT00495898
Study groupRoleWhat they receive
1ExperimentalCYPHER sirolimus-eluting stent
Receives: Device: CYPHER sirolimus-eluting stent
2Active comparatoruncoated Bx VELOCITY balloon-expandable stent
Receives: Device: uncoated Bx VELOCITY balloon-expandable stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. angiographic in-segment late loss

    Measured: 8 months post-procedure

Secondary outcomes (10)

  1. late loss

    Measured: 8 months post-procedure

  2. angiographic binary restenosis

    Measured: 8 months post-procedure

  3. target lesion revascularization (TLR)

    Measured: 8 months post-procedure

  4. target vessel revascularization (TVR)

    Measured: 8 months post-procedure

  5. target vessel failure (TVF)

    Measured: 8 months post-procedure

  6. procedure success

    Measured: 8 months post-procedure

  7. lesion success rate

    Measured: 0

  8. resource use

    Measured: 1 year post-procedure

  9. productivity loss

    Measured: 1 year post-procedure

  10. Major Adverse Cardiac Events (MACE)

    Measured: 30 days, and 8 and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2007 (estimated)
  2. Study startNov 2002
  3. Primary completionMay 2005
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00495898
Sponsor's protocol ID
CRDDE-001
Acronym
SCORPIUS
Status last verified
Dec 2009
First submitted
2 Jul 2007
Last updated
3 Dec 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17950142

  • 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.

    PubMed 22424016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CYPHER sirolimus-eluting stent and uncoated Bx VELOCITY balloon-expandable stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

angiographic in-segment late loss (time frame: 8 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00495898, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2009.

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