NCT00225680

Brief Summary

This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2002

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

First QC Date

September 12, 2005

Last Update Submit

January 30, 2012

Conditions

Coronary Artery Disease

Keywords

coronary arterystentdrug elutingpatencyrestenosis

Outcome Measures

Primary Outcomes (1)

  • Angiographic target vessel failure (TVF) at follow up

Secondary Outcomes (2)

  • Major adverse events

  • Target lesion revascularization

Interventions

drug eluting coronary stentDEVICE

Eligibility Criteria

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

You may qualify if:

  • Patient has given informed consent
  • Patient has target lesion in native coronary artery or coronary bypass graft
  • Patient has in-stent restenosis \>60%
  • Patient has reference artery diameter 2.7-3.5
  • Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months.

You may not qualify if:

  • Patient is less than 18 years of age
  • Patient is pregnant or breast feeding
  • Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study.
  • Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Sponsor

Bloomington, Indiana, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ivan DeScheerder, MD

    University Hospital of Gathuisberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 26, 2005

Study Start

April 1, 2002

Study Completion

August 1, 2005

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

US(1)