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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00232739
First received: October 3, 2005
Last updated: March 11, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: CYPHER Sirolimus-eluting Coronary Stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From post-procedure to 4 years ] [ Designated as safety issue: No ]
    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. [ Time Frame: From post-procedure to 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: From post-procedure to 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: From post-procedure to 6 months and 9 months follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From post-procedure to 6 months and 9 months follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: At Post-procedure ] [ Designated as safety issue: No ]
  • Average Stent Obstruction Volume at Post-procedure [ Time Frame: At post-procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: From post-procedure to 6 months ] [ Designated as safety issue: No ]
  • Average Stent Obstruction Volume at 6 Months Post-procedure [ Time Frame: From post-procedure to 6 months ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Achieved Lesion Success at Post-procedure [ Time Frame: At post-procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: At post-procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: From post-procedure to hospital discharge ] [ Designated as safety issue: Yes ]
    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


Enrollment: 100
Study Start Date: September 2003
Study Completion Date: August 2009
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: CYPHER Sirolimus-eluting Coronary Stent
2.25 Cypher Sirolimus-eluting Coronary Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232739

Locations
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Sriram Iyer, MD Lenox Hill Hospital
  More Information

Publications:
Responsible Party: Sriram Iyer, MD, Lenox Hill Hospital
ClinicalTrials.gov Identifier: NCT00232739     History of Changes
Other Study ID Numbers: P03-6320
Study First Received: October 3, 2005
Results First Received: October 19, 2009
Last Updated: March 11, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014