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Completed

NCT Number: NCT00231244

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Scripps Clinic and Research

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CYPHER Sirolimus-eluting Coronary Stent

Device

CYPHER Sirolimus-Eluting Coronary Stent

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Oct 4, 2005
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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