NCT00855478

Brief Summary

To assess the safety and effecacy of the Cypher stent ™ \& Cypher Select ™ in the normal use of medical practices, within the labeled indications.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,080

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2006

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
Last Updated

November 29, 2010

Status Verified

November 1, 2010

Enrollment Period

2.3 years

First QC Date

March 3, 2009

Last Update Submit

November 25, 2010

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • There is no pre-specified endpoint.

    12 Months

Study Arms (1)

1

EXPERIMENTAL

Cypher drug-eluting stent

Device: Cypher stent ™ or Cypher Select ™

Interventions

Cypher stent ™ or Cypher Select ™DEVICE

Cypher drug-eluting stent

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic ischemic heart disease due to de novo lesions (lesions \<30 mm vessel reference diameter of 2.25 mm to 5 mm), assessed visually, native coronary arteries.

You may not qualify if:

  • Patients suffering from coronary heart disease.
  • Patients for whom treatment antiplatelet and / or anticoagulant is against the state;
  • Patients with injuries incompatible with the full inflation of a balloon angioplasty;
  • Transplant patients ;
  • Patients with known allergy to Sirolimus, the stainless steel 316L, to polymethacrylates or copolymers polyolefins;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

May 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 29, 2010

Record last verified: 2010-11