Back to resultsDouble or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions (3D)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
CYPHER Sirolimus-Eluting Coronary Stent
CYPHER Sirolimus-Eluting Coronary Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: 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); Exclusion Criteria: 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);
Sites / Locations
- Institute Dante Pazzanese of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Single-dose Sirolimus-Eluting Coronary stent
Double-dose Sirolimus-Eluting Coronary stent
Outcomes
Primary Outcome Measures
The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure.
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.
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.
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.
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.
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.
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.
In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years.
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.
In-lesion late lumen loss measured by QCA at 6 months and 2 years.
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years.
Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months.
C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233714
Brief Title
Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions
Acronym
3D
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Single-dose Sirolimus-Eluting Coronary stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
Double-dose Sirolimus-Eluting Coronary stent
Intervention Type
Device
Intervention Name(s)
CYPHER Sirolimus-Eluting Coronary Stent
Other Intervention Name(s)
Cypher Bx Velocity
Intervention Description
Single dose Sirolimus-Eluting coronary stent
Intervention Type
Device
Intervention Name(s)
CYPHER Sirolimus-Eluting Coronary Stent
Other Intervention Name(s)
Cypher Bx Velocity
Intervention Description
Double-dose Sirolimus-Eluting coronary stent
Primary Outcome Measure Information:
Title
The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure.
Time Frame
6 months post-procedure
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.
Time Frame
During Index Procedure
Title
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
Title
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
Title
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
Title
In-lesion late lumen loss measured by QCA at 6 months and 2 years.
Time Frame
6 months and 2 years
Title
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.
Title
Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months.
Time Frame
baseline, 6, 12, and 24 months
Title
C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes.
Time Frame
baseline, 6, 12, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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);
Exclusion Criteria:
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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose E. Sousa, MD
Organizational Affiliation
Institute Dante Pazzanese of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute Dante Pazzanese of Cardiology
City
Sao Paolo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19755304
Citation
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.
Results Reference
result
PubMed Identifier
18688066
Citation
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.
Results Reference
result
Learn more about this trial
Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions
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