Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

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:

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;

Contacts and Locations

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

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 21, 2013