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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
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: CYPHER Sirolimus-Eluting Coronary Stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 252
Study Start Date: March 2002
Study Completion Date: November 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CYPHER Sirolimus-Eluting Coronary Stent
Device: CYPHER Sirolimus-Eluting Coronary Stent
CYPHER Sirolimus-Eluting Coronary Stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 3, 2005
Last Updated: December 4, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014