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Completed

NCT Number: NCT00232739

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lenox Hill Hospital

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

CYPHER Sirolimus-eluting Coronary Stent

Device

2.25 Cypher Sirolimus-eluting Coronary Stent

Primary outcomes

  1. Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure

    Time frame: From post-procedure to 6 months

    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 outcomes

  1. Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up

    Time frame: From post-procedure to 4 years

    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).

  2. Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.

    Time frame: From post-procedure to 6 months

    In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.

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

    Time frame: From post-procedure to 6 months

  4. Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.

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

    TLR was defined as any "clinically-driven" repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.

  5. Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.

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

    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.

  6. Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure

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

    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.

  7. Average Lumen Volume (mm3) at Post-procedure

    Time frame: At Post-procedure

  8. Average Stent Obstruction Volume at Post-procedure

    Time frame: 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

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

    Time frame: From post-procedure to 6 months

  10. Average Stent Obstruction Volume at 6 Months Post-procedure

    Time frame: From post-procedure to 6 months

  11. Percentage of Participants Who Achieved Lesion Success at Post-procedure

    Time frame: At post-procedure

    Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method

  12. Percentage of Participants Who Achieved Device Success at Post-procedure

    Time frame: 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

  13. Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge

    Time frame: From post-procedure to 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

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2009
First posted
Oct 5, 2005
Registry last updated
Mar 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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