Study of the 4.0mm 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:
NCT00232752
First received: October 3, 2005
Last updated: December 1, 2009
Last verified: December 2009
  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 late loss in patients with de novo native coronary artery lesions.


Condition Intervention Phase
Coronary Artery Disease
Device: 4.0 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 4.0mm 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:
  • The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (TLR) at 6 and 9 months post-procedure. [ Time Frame: 6 and 9 months post-procedure ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (TVR) at 6 and 9 months post-procedure. [ Time Frame: 6 and 9 months post-procedure ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF) at 6 and 9 months post-procedure. [ Time Frame: 6 and 9 months post-procedure ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: September 2003
Study Completion Date: November 2009
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: 4.0 CYPHER Sirolimus-Eluting Coronary Stent
4.0 CYPHER Sirolimus-Eluting Coronary Stent

  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 lesions treatable with 4mm stent (visual estimate);
  4. Target lesion is 30mm in length (visual estimate);
  5. 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: NCT00232752

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Mauri Laura, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Mauri Laura, MD, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00232752     History of Changes
Other Study ID Numbers: P03-6319
Study First Received: October 3, 2005
Last Updated: December 1, 2009
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 October 01, 2014