Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions (3D)

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00233714
First received: October 4, 2005
Last updated: November 17, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: CYPHER Sirolimus-Eluting Coronary Stent
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: During Index Procedure ] [ Designated as safety issue: Yes ]
  • Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. [ Time Frame: During Index Procedure ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: During the hospital stay ] [ Designated as safety issue: Yes ]
  • In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years. [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: post-procedure and at 6 months and 2 years ] [ Designated as safety issue: Yes ]
  • In-lesion late lumen loss measured by QCA at 6 months and 2 years. [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: Yes ]
  • Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years. [ Time Frame: post-procedure 6 months and 2 years. ] [ Designated as safety issue: Yes ]
  • Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months. [ Time Frame: baseline, 6, 12, and 24 months ] [ Designated as safety issue: Yes ]
  • C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes. [ Time Frame: baseline, 6, 12, and 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: May 2003
Study Completion Date: November 2009
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Single-dose Sirolimus-Eluting Coronary stent
Device: CYPHER Sirolimus-Eluting Coronary Stent
Single dose Sirolimus-Eluting coronary stent
Other Name: Cypher Bx Velocity
Active Comparator: 2
Double-dose Sirolimus-Eluting Coronary stent
Device: CYPHER Sirolimus-Eluting Coronary Stent
Double-dose Sirolimus-Eluting coronary stent
Other Name: Cypher Bx Velocity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must be minimum 18 years of age;
  2. Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
  3. 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;
  4. 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;
  5. The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
  6. The target lesion is <30 mm in length (visual estimate) located in a native coronary artery;
  7. Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);

Exclusion Criteria:

  1. 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;
  2. Patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (Brittle Diabetics);
  3. Ejection fraction 30%;
  4. Impaired renal function (creatinine > 2.0 mg/dL);
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233714

Locations
Brazil
Institute Dante Pazzanese of Cardiology
Sao Paolo, Brazil
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Jose E. Sousa, MD Institute Dante Pazzanese of Cardiology
  More Information

Publications:
Responsible Party: Sid Cohen, MD, VP, Cordis
ClinicalTrials.gov Identifier: NCT00233714     History of Changes
Other Study ID Numbers: P03-6318
Study First Received: October 4, 2005
Last Updated: November 17, 2009
Health Authority: Israel: Ministry of Health
Italy: Ministry of Health
Brazil: National Committee of Ethics in Research

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 April 14, 2014