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

Cordis

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Device: CYPHER Sirolimus-Eluting Coronary Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231244

P01-6310

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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252 participants in 1 patient group

1

Experimental group

Description:

CYPHER Sirolimus-Eluting Coronary Stent

Treatment:

Device: CYPHER Sirolimus-Eluting Coronary Stent