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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

October 3, 2005
December 4, 2009
March 2002
May 2008   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00231244 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: CYPHER Sirolimus-Eluting Coronary Stent
CYPHER Sirolimus-Eluting Coronary Stent
Experimental: 1
CYPHER Sirolimus-Eluting Coronary Stent
Intervention: Device: CYPHER Sirolimus-Eluting Coronary Stent
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
November 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231244
P01-6310
No
Sid Cohen, MD, Cordis
Cordis Corporation
Not Provided
Principal Investigator: Paul Teirstein, MD Scripps Clinic and Research
Cordis Corporation
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP