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Coronary Artery DiseasePhase 1/23DNCT00233714

Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions

A Phase 1/2 study testing CYPHER Sirolimus-Eluting Coronary Stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Brazil.

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 safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents. 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 Coronary Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteBrazil
Study dates
May 2003to Nov 2009
Phase
Phase 1/2
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

  • The patient must be minimum 18 years of age;
  • Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
  • Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
  • Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
  • The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
  • The target lesion is <30 mm in length (visual estimate) located in a native coronary artery;
  • Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);

Who cannot join

  • Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
  • Patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (Brittle Diabetics);
  • Ejection fraction 30%;
  • Impaired renal function (creatinine > 2.0 mg/dL);

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Institute Dante Pazzanese of Cardiology

    São Paulo

Other trials in Brazil

About this study

Official title: A Randomized Feasibility Study of the Double Dose or Single Dose Sirolimus-Eluting BX VELOCITY Balloon-Expandable Stent for the Treatment of Diabetic Patients With de Novo Native Coronary Artery Lesions(3D)

The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.

Being tested
CYPHER Sirolimus-Eluting Coronary 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 Coronary StentDevice

    Also called Cypher Bx Velocity

    Single dose Sirolimus-Eluting coronary stent

  • CYPHER Sirolimus-Eluting Coronary StentDevice

    Also called Cypher Bx Velocity

    Double-dose Sirolimus-Eluting coronary stent

Study groups in NCT00233714
Study groupRoleWhat they receive
1Active comparatorSingle-dose Sirolimus-Eluting Coronary stent
Receives: Device: CYPHER Sirolimus-Eluting Coronary Stent
2Active comparatorDouble-dose Sirolimus-Eluting Coronary stent
Receives: Device: CYPHER Sirolimus-Eluting Coronary Stent

What is being measured

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

  1. The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure.

    Measured: 6 months post-procedure

Secondary outcomes (12)

  1. Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure.

    Measured: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure

  2. Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure.

    Measured: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure

  3. Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure.

    Measured: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure

  4. Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.

    Measured: During Index Procedure

  5. Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.

    Measured: During Index Procedure

  6. Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.

    Measured: During the hospital stay

  7. In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years.

    Measured: 6 months and 2 years

  8. In-stent and in-lesion mean percent diameter stenosis (%DS) and minimal lumen. diameter (MLD) measured by QCA post-procedure and at 6 months and 2 years.

    Measured: post-procedure and at 6 months and 2 years

  9. In-lesion late lumen loss measured by QCA at 6 months and 2 years.

    Measured: 6 months and 2 years

  10. Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years.

    Measured: post-procedure 6 months and 2 years.

  11. Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months.

    Measured: baseline, 6, 12, and 24 months

  12. C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes.

    Measured: baseline, 6, 12, and 24 months

Timeline

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

  1. First posted6 Oct 2005 (estimated)
  2. Study startMay 2003
  3. Primary completionJul 2004
  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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00233714
Sponsor's protocol ID
P03-6318
Acronym
3D
Status last verified
Nov 2009
First submitted
4 Oct 2005
Last updated
19 Nov 2009
Results posted
No
Data monitoring committee
No

Publications

  • Costa RA, Sousa JE, Abizaid A, Chaves A, Feres F, Sousa AG, Musumeci G, Mehran R, Fitzgerald PJ, Lansky AJ, Leon MB, Shiran A, Halon DA, Lewis BS, Guagliumi G. The randomised study of the double dose versus single dose sirolimus-eluting stent for the treatment of diabetic patients with de novo coronary lesions. EuroIntervention. 2006 Nov;2(3):295-301.

    PubMed 19755304

  • Hur SH, Ako J, Shimada Y, Tsujino I, Hassan AH, Abizaid A, Shiran A, Lewis BS, Guagliumi G, Cohen SA, Honda Y, Fitzgerald PJ, Sousa JE. Two-year intravascular ultrasound observations in diabetic patients treated with single and double dose sirolimus-eluting stents: results of the double dose diabetes (3D) study. J Invasive Cardiol. 2008 Aug;20(8):411-6.

    PubMed 18688066

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CYPHER Sirolimus-Eluting Coronary Stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Brazil.

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 7 inclusion and 4 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 19 Nov 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 Brazil. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure. (time frame: 6 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 NCT00233714, 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 19 Nov 2009.

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