NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions - Full Text View

Sponsor:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00231283

Purpose

The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.

Condition	Intervention	Phase
Coronary Artery Disease	Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)	Phase III

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 CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge [ Time Frame: From post-procedure up to hospital discharge ] [ Designated as safety issue: Yes ]
Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion

Secondary Outcome Measures:

Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later [ Time Frame: From post-procedure up to 30 days ] [ Designated as safety issue: Yes ]
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 Major Adverse Cardiac Events From Post-procedure to Hospital Discharge [ Time Frame: From post-procedure up to hospital discharge ] [ Designated as safety issue: Yes ]
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 Major Adverse Cardiac Events From Post-procedure to 12 Months Later [ Time Frame: From post-procedure up to 12 months ] [ Designated as safety issue: Yes ]
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).

Enrollment:	100
Study Start Date:	April 2004
Study Completion Date:	July 2005

Arms	Assigned Interventions
Experimental: 1 CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System	Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System

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 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;
Treatment of a single de novo target lesion in a major native coronary artery;
Target lesion is 2.5 mm and 3.5 mm in diameter (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 remain above normal at the time of treatment;
Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Documented Left ventricular ejection fraction 25%;
Totally occluded vessel (TIMI 0 level);
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: NCT00231283

Locations

United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

Emerson Perin, MD

Texas Heart Institute

More Information

No publications provided

Responsible Party:	Sidney Cohen, MD, PhD, Vice President, Cordis
ClinicalTrials.gov Identifier:	NCT00231283 History of Changes
Other Study ID Numbers:	P04-6324
Study First Received:	September 30, 2005
Results First Received:	November 18, 2008
Last Updated:	April 13, 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
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 February 12, 2012