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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014