NCT00422435

Brief Summary

This study is designed to evaluate the performance and safety of a new catheter system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_3

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

January 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 24, 2008

Status Verified

October 1, 2008

Enrollment Period

4 months

First QC Date

January 15, 2007

Last Update Submit

October 23, 2008

Conditions

Coronary Disease

Keywords

Percutaneous coronary intervention (PCI)Drug eluting stent (DES)

Outcome Measures

Primary Outcomes (1)

  • Device Success

    At procedure or hospital discharge

Secondary Outcomes (4)

  • Lesion success

    30 days, 6 months and 12 months

  • Procedure success

    30 days, 6 months and 12 months

  • Acute Device Performance

    Index procedure

  • In hospital, 30-day, 6-month, 12-month MACE

    30-day, 6-month, 12-month

Study Arms (1)

Drug eluting stent

EXPERIMENTAL

CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter

Device: CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter

Interventions

CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheterDEVICE

Paclitaxel-Eluting Coronary Stent

Drug eluting stent

Eligibility Criteria

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

You may qualify if:

  • Patient ≥18 years of age
  • Eligible for percutaneous coronary intervention
  • Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification 1, 2, 3, or 4), documented ischemia, or documented silent ischemia
  • Left ventricular ejection fraction ≥25% documented within the last 6 wks
  • Acceptable candidate for coronary artery bypass graft surgery
  • A single de novo lesion per study subject may be treated with the study device
  • Each target lesion may be composed of multiple lesions but must be completely coverable by 1 study stent
  • Cumulative target lesion length per vessel ≤30 mm based on a visual estimate
  • RVD ≥2.5 mm to ≤3.0 mm based on a visual estimate
  • Target lesion diameter stenosis ≥50% and \<100% based on a visual estimate
  • Target vessel has not undergone prior revascularization within the preceding 6 months
  • Target lesion must be a minimum 10 mm distance from any previously treated segment of the target vessel

You may not qualify if:

  • Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: Translute or PLGA
  • Planned treatment with any other PCI device in the target vessel(s)
  • MI within 72 hours prior to the index procedure
  • Patient is in cardiogenic shock
  • Cerebrovascular Accident within the past 6 months
  • Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/L)
  • Contraindication to ASA or to clopidogrel
  • Thrombocytopenia (platelet count \<100, 000/mm3)
  • Active gastrointestinal bleeding within the past three months
  • Any prior true anaphylactic reaction to contrast agents
  • Patient is currently, or has been treated with paclitaxel (systemic) within 12 months of the index procedure
  • Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the study
  • Life expectancy of less than 24 months due to other medical conditions
  • Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  • Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Christophe Dubois, M.D.

    UH Gasthuisberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 15, 2007

First Posted

January 17, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2008

Last Updated

October 24, 2008

Record last verified: 2008-10

Locations

BE(1)