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

This study is ongoing, but not recruiting participants.

Sponsored by: Cordis Corporation
Information provided by: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00232739
  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 III

MedlinePlus related topics:   Coronary Artery Disease   

ChemIDplus related topics:   Sirolimus   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • The primary endpoint is in-lesion restenosis 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 binary restenosis (50% diameter stenosis) 6 months post-procedure. [ 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 ]

Enrollment:   100
Study Start Date:   September 2003
Estimated Study Completion Date:   May 2009
Primary Completion Date:   November 2004 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental 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

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:   Lenox Hill Hospital ( Sriram Iyer, MD )
Study ID Numbers:   P03-6320
First Received:   October 3, 2005
Last Updated:   April 17, 2008
ClinicalTrials.gov Identifier:   NCT00232739
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clotrimazole
Miconazole
Myocardial Ischemia
Tioconazole
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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