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Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00232739
Enrollment
100
Registered
2005-10-05
Start date
2003-09-30
Completion date
2009-08-31
Last updated
2010-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICECYPHER Sirolimus-eluting Coronary Stent

2.25 Cypher Sirolimus-eluting Coronary Stent

Sponsors

Cordis US Corp.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male or non-pregnant female patients minimum 18 years of age 2. 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; 3. Target lesion is 20mm in length (visual estimate); 4. Target lesion stenosis is \>50% and \<100% (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. Has unstable angina classified as Braunwald III B or C, or is having a peri infarction; 3. Documented Left ventricular ejection fraction 25%; 4. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedureFrom post-procedure to 6 monthsIn-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

MeasureTime frameDescription
Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.From post-procedure to 6 monthsIn-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.From post-procedure to 6 months—
Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.From post-procedure to 6 months and 9 monthsTLR 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.From post-procedure to 6 months and 9 months follow-upTVR 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-procedureFrom post-procedure to 6 months and 9 months follow-upTVF 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-procedureAt Post-procedure—
Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-upFrom post-procedure to 4 yearsThe 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).
Average Lumen Volume (mm3) at 6 Months Post-procedureFrom post-procedure to 6 months—
Average Stent Obstruction Volume at 6 Months Post-procedureFrom post-procedure to 6 months—
Percentage of Participants Who Achieved Lesion Success at Post-procedureAt post-procedureLesion 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-procedureAt post-procedureDevice 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 DischargeFrom post-procedure to hospital dischargeProcedure 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
Average Stent Obstruction Volume at Post-procedureAt post-procedureStent 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

Countries

United States

Participant flow

Participants by arm

ArmCount
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
100
Total100

Baseline characteristics

Characteristic2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
48 Participants
Age, Categorical
Between 18 and 65 years
52 Participants
Age Continuous63.4 years
STANDARD_DEVIATION 9.9
Diabetes Mellitus
Diabetes Mellitus
40 participants
Diabetes Mellitus
Without Diabetes Mellitus
60 participants
History of Myocardial Infarction (MI)
History of MI
33 participants
History of Myocardial Infarction (MI)
N/A
6 participants
History of Myocardial Infarction (MI)
Without History of MI
61 participants
Region of Enrollment
United States
100 participants
Sex: Female, Male
Female
36 Participants
Sex: Female, Male
Male
64 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
39 / 96
serious
Total, serious adverse events
5 / 91

Outcome results

Primary

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.

Time frame: From post-procedure to 6 months

Population: The number of participants with six months follow up and non-missing six months binary angiographic restenosis (BAR) results.

ArmMeasureValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentPercentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure16.9 Percentage of participants
Comparison: Historical control groups consist of propensity-scored matched cohorts (100 patients each, based on Reference Vessel Diameter, lesion length, diabetes, left anterior artery diseased vessel, and gender) of plain old balloon angioplasty (POBA), first generation (Palmaz-Schatz) bare metal stent (BMS1), and BX VELOCITY bare metal stent (BMS2). Study showed the risk of 6-month in-lesion binary angiographic restenosis (BAR) was much lower for the 2.25 Sirolimus stent compared with POBA, BMS1 or BMS2.Bayesian regression model
Secondary

Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.

Time frame: From post-procedure to 6 months

Population: The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.

ArmMeasureGroupValue (MEAN)Dispersion
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentAverage In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.Average In-stent MLD1.64 mmStandard Deviation 0.52
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentAverage In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.Average In-lesion MLD1.35 mmStandard Deviation 0.45
Secondary

Average Lumen Volume (mm3) at 6 Months Post-procedure

Time frame: From post-procedure to 6 months

Population: The number of participants who had Lumen Volume data at 6 months post-procedure

ArmMeasureValue (MEAN)Dispersion
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentAverage Lumen Volume (mm3) at 6 Months Post-procedure70.25 mm3Standard Deviation 25.61
Secondary

Average Lumen Volume (mm3) at Post-procedure

Time frame: At Post-procedure

Population: The number of participants who had lumen volume data at post-procedure

ArmMeasureValue (MEAN)Dispersion
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentAverage Lumen Volume (mm3) at Post-procedure73.34 mm3Standard Deviation 38.32
Secondary

Average Stent Obstruction Volume at 6 Months Post-procedure

Time frame: From post-procedure to 6 months

Population: The number of participants with Stent Obstruction Volume data at 6 months post-procedure

ArmMeasureValue (MEAN)Dispersion
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentAverage Stent Obstruction Volume at 6 Months Post-procedure3.05 mm3Standard Deviation 2.42
Secondary

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

Time frame: At post-procedure

Population: Number of participants who had Stent Obstruction Volume data at post-procedure

ArmMeasureValue (MEAN)Dispersion
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentAverage Stent Obstruction Volume at Post-procedure0.0 mm3Standard Deviation 0
Secondary

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).

Time frame: From post-procedure to 4 years

Population: The number of participants who had four years post-procedure follow up or who had at least one event prior to the end of follow-up.

ArmMeasureGroupValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up2 Years Post-Procedure17.0 Percentage of participants
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up6 Months Post-Procedure8.0 Percentage of participants
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up9 Months Post-Procedure9.0 Percentage of participants
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up12 Months Post-Procedure11.0 Percentage of participants
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up3 Years Post-Procedure21.0 Percentage of participants
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up4 Years Post-Procedure27.4 Percentage of participants
Secondary

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.

Time frame: From post-procedure to 6 months and 9 months

Population: The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.

ArmMeasureGroupValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.6 Months Post-Procedure5.1 Percentage of participants
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.9 Months Post-Procedure6.1 Percentage of participants
Secondary

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.

Time frame: From post-procedure to 6 months and 9 months follow-up

Population: The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.

ArmMeasureGroupValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure6 Months Post-Procedure11.0 Percentage of participants
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure9 Months Post-Procedure13.0 Percentage of participants
Secondary

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.

Time frame: From post-procedure to 6 months and 9 months follow-up

Population: The number of participants who had sufficient 9 months post-procedure follow-up or had the event prior to 9 months.

ArmMeasureGroupValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.6 Months Post-Procedure8.1 Percentage of participants
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentCumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.9 Months Post-Procedure10.1 Percentage of participants
Secondary

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

Time frame: At post-procedure

Population: All participants

ArmMeasureValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentPercentage of Participants Who Achieved Device Success at Post-procedure96.0 Percentage of participants
Secondary

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

Time frame: At post-procedure

Population: Number of Participants without missing lesion success data

ArmMeasureValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentPercentage of Participants Who Achieved Lesion Success at Post-procedure98.0 Percentage of participants
Secondary

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

Time frame: From post-procedure to hospital discharge

Population: Number of participants without missing procedure success data

ArmMeasureValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentPercentage of Participants Who Achieved Procedure Success Before Hospital Discharge97.0 Percentage of participants
Secondary

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.

Time frame: From post-procedure to 6 months

Population: The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.

ArmMeasureValue (MEAN)
2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp StentPercentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.11.7 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026