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Completed

NCT Number: NCT00232752

Study of the 4.0mm 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 late loss 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

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

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 lesions treatable with 4mm stent (visual estimate);
  • Target lesion is 30mm 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

4.0 CYPHER Sirolimus-Eluting Coronary Stent

Device

4.0 CYPHER Sirolimus-Eluting Coronary Stent

Primary outcomes

  1. The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.

    Time frame: 6 months post-procedure

Secondary outcomes

  1. 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 and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced

    Time frame: 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure

  2. Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.

    Time frame: 6 months post-procedure

  3. In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.

    Time frame: 6 months post-procedure

  4. Target lesion revascularization (TLR) at 6 and 9 months post-procedure.

    Time frame: 6 and 9 months post-procedure

  5. Target vessel revascularization (TVR) at 6 and 9 months post-procedure.

    Time frame: 6 and 9 months post-procedure

  6. Target vessel failure (TVF) at 6 and 9 months post-procedure.

    Time frame: 6 and 9 months post-procedure

  7. Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers.

    Time frame: post-procedure and six months in a subset of approximately 50 patients

  8. 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: End of study

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

    Time frame: End of Study

  10. 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

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study title

A Multicenter, Non-Randomized Study of the 4.0mm 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
2005
Study completion
2009
First posted
Oct 5, 2005
Registry last updated
Dec 2, 2009

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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