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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 29, 2014