Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)

This study has been completed.

Sponsor:

Information provided by:

Cordis Corporation

ClinicalTrials.gov Identifier:

NCT00231244

First received: October 3, 2005

Last updated: December 4, 2009

Last verified: December 2009

History of Changes

Purpose

The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM stent in patients with a serious disease or condition for which there is no generally acceptable alternate treatment available.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry

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 of this study is a composite of Target Vessel Failure (TVF) defined as target vessel revascularization, myocardial infarction or cardiac death at 30 days, 6mo, 12mo, 2, 3, 4, and 5 years. [ Time Frame: 30 days, 6mo, 12mo, 2, 3, 4, and 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	252
Study Start Date:	March 2002
Study Completion Date:	November 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 CYPHER Sirolimus-Eluting Coronary Stent	Device: CYPHER Sirolimus-Eluting Coronary Stent 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 patient minimum 18 years of age
There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;

Exclusion Criteria:

There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy;
The study target lesion has definite or possible thrombus present by angiographic criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231244

Locations

United States, California
Scripps Clinic and Research
LaJolla, California, United States, 92037

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

Paul Teirstein, MD

Scripps Clinic and Research

More Information

Publications:

Costa M, Angiolillo DJ, Teirstein P, Gilmore P, Leon M, Moses J, Yakubov S, Carter A, Fischell T, Zenni M, Bass T. Sirolimus-eluting stents for treatment of complex bypass graft disease: insights from the SECURE registry. J Invasive Cardiol. 2005 Aug;17(8):396-8.

Responsible Party:	Sid Cohen, MD, Cordis
ClinicalTrials.gov Identifier:	NCT00231244 History of Changes
Other Study ID Numbers:	P01-6310
Study First Received:	October 3, 2005
Last Updated:	December 4, 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 22, 2013

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