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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231244
• Other study ID #: P01-6310
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2005
• Last updated: December 4, 2009
• Start date: March 2002
• Est. completion date: November 2008

Study information

• Verified date: December 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: November 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• CYPHER Sirolimus-Eluting Coronary Stent
CYPHER Sirolimus-Eluting Coronary Stent

Locations

Country	Name	City	State
United States	Scripps Clinic and Research	LaJolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 days, 6mo, 12mo, 2, 3, 4, and 5 years	Yes