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

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ClinicalTrials.gov Identifier: NCT00231244
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: CYPHER Sirolimus-Eluting Coronary Stent Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry
Study Start Date : March 2002
Primary Completion Date : May 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
CYPHER Sirolimus-Eluting Coronary Stent
Device: CYPHER Sirolimus-Eluting Coronary Stent
CYPHER Sirolimus-Eluting Coronary Stent


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or non-pregnant female patient minimum 18 years of age
  2. There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
  3. Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
  4. Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Sid Cohen, MD, Cordis
ClinicalTrials.gov Identifier: NCT00231244     History of Changes
Other Study ID Numbers: P01-6310
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

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
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs