Back to resultsStudy of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CYPHER Sirolimus-eluting Coronary Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant female patients minimum 18 years of age 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) OR patients with documented silent ischemia; Target lesion is 20mm in length (visual estimate); Target lesion stenosis is >50% and <100% (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; Has unstable angina classified as Braunwald III B or C, or is having a peri infarction; Documented Left ventricular ejection fraction 25%; Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Sites / Locations
- Lenox Hill Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure
In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.
Secondary Outcome Measures
Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.
In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.
Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.
Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.
TLR was defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.
Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.
TVR was defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations were those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis being greater than or equal to 50 percent measured by QCA.
Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure
TVF was defined as any Target vessel revascularization, Q wave or non-Q wave MI, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
Average Lumen Volume (mm3) at Post-procedure
Average Stent Obstruction Volume at Post-procedure
Stent obstruction Volume equals 100 * [1-(lumen volume/baseline stent volume)]; usually this is equal to zero at baseline, since the stent is freshly implanted and no obstruction is expected
Average Lumen Volume (mm3) at 6 Months Post-procedure
Average Stent Obstruction Volume at 6 Months Post-procedure
Percentage of Participants Who Achieved Lesion Success at Post-procedure
Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method
Percentage of Participants Who Achieved Device Success at Post-procedure
Device success was defined as achievement of a final residual diameter stenosis of less than 50 percent as measured by QCA, using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used
Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge
Procedure success defined as achievement of a final diameter stenosis of less than 50 percent (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232739
Brief Title
Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Official Title
A Multicenter, Non-Randomized Study of the 2.25mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.
Detailed Description
This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in patients with de novo native coronary artery lesions. A total of 100 patients will be entered in the study. Patients who meet the eligibility criteria will be enrolled into the study. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 6 months. Approximately 50 patients will be required to have an intravascular ultrasound (IVUS) procedure at baseline and at the 6-month angiographic follow-up.
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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CYPHER Sirolimus-eluting Coronary Stent
Intervention Description
2.25 Cypher Sirolimus-eluting Coronary Stent
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure
Description
In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.
Time Frame
From post-procedure to 6 months
Secondary Outcome Measure Information:
Title
Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
Description
The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Time Frame
From post-procedure to 4 years
Title
Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.
Description
In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.
Time Frame
From post-procedure to 6 months
Title
Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.
Time Frame
From post-procedure to 6 months
Title
Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.
Description
TLR was defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.
Time Frame
From post-procedure to 6 months and 9 months
Title
Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.
Description
TVR was defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations were those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis being greater than or equal to 50 percent measured by QCA.
Time Frame
From post-procedure to 6 months and 9 months follow-up
Title
Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure
Description
TVF was defined as any Target vessel revascularization, Q wave or non-Q wave MI, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
Time Frame
From post-procedure to 6 months and 9 months follow-up
Title
Average Lumen Volume (mm3) at Post-procedure
Time Frame
At Post-procedure
Title
Average Stent Obstruction Volume at Post-procedure
Description
Stent obstruction Volume equals 100 * [1-(lumen volume/baseline stent volume)]; usually this is equal to zero at baseline, since the stent is freshly implanted and no obstruction is expected
Time Frame
At post-procedure
Title
Average Lumen Volume (mm3) at 6 Months Post-procedure
Time Frame
From post-procedure to 6 months
Title
Average Stent Obstruction Volume at 6 Months Post-procedure
Time Frame
From post-procedure to 6 months
Title
Percentage of Participants Who Achieved Lesion Success at Post-procedure
Description
Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method
Time Frame
At post-procedure
Title
Percentage of Participants Who Achieved Device Success at Post-procedure
Description
Device success was defined as achievement of a final residual diameter stenosis of less than 50 percent as measured by QCA, using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used
Time Frame
At post-procedure
Title
Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge
Description
Procedure success defined as achievement of a final diameter stenosis of less than 50 percent (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
From post-procedure to hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant female patients minimum 18 years of age
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) OR patients with documented silent ischemia;
Target lesion is 20mm in length (visual estimate);
Target lesion stenosis is >50% and <100% (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;
Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
Documented Left ventricular ejection fraction 25%;
Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Iyer, MD
Organizational Affiliation
Lenox Hill Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17126649
Citation
Moses JW, Nikolsky E, Mehran R, Cambier PA, Bachinsky WB, Leya F, Kuntz RE, Popma JJ, Schleckser P, Wang H, Cohen SA, Leon MB; SIRIUS 2.25 Investigators. Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial. Am J Cardiol. 2006 Dec 1;98(11):1455-60. doi: 10.1016/j.amjcard.2006.06.047. Epub 2006 Oct 13.
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Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
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