Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions (3D)
This study has been completed.
Sponsor:
Cordis Corporation
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00233714
First received: October 4, 2005
Last updated: November 17, 2009
Last verified: November 2009
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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:
- 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);
Contacts and Locations More Information
Publications:
Costa R, Sousa JE, et al. The radomised study of the double dose versus single dose sirolimus-eluting stent for the treatment of diabetic patients with de novo coronary lesions. EuroInterv.2006;2:295-301
| 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 May 22, 2013