CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

October 23, 2008 updated by: Conor Medsystems

The PreCiSE Trial: CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to evaluate acute Device Success, defined as attainment of <50% residual stenosis of the target lesion.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UH Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Left main coronary artery disease (stenosis >50%), whether protected or unprotected
  • Target lesion is ostial in location (within 3.0 mm of vessel origin)
  • Target lesion and/or target vessel proximal to the target lesion is severely calcified by visual estimation
  • Target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter that requires intervention
  • Target lesion is totally occluded Thrombolysis In MI (TIMI flow ≤1)
  • Angiographic presence of probable or definite thrombus
  • Target vessel will be pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
  • Prior coronary intervention using brachytherapy to any segment of the target vessel
  • The target vessel has had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site
  • Angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous coronary intervention
  • Angiographic evidence of atherosclerotic disease with > 50% diameter stenosis (by visual estimate) proximal or distal to the target lesion (applies to the major epicardial portion of the target vessel and contiguous vessel segment if the target lesion is located in a branch vessel)
  • Prior surgical revascularization of the target vessel with patent graft (saphenous vein graft or arterial conduit)
  • Target lesion lies within 10 mm of prior surgical anastomosis site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug eluting stent
CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter
Device: CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter
Paclitaxel-Eluting Coronary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device Success
Time Frame: At procedure or hospital discharge
At procedure or hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Lesion success
Time Frame: 30 days, 6 months and 12 months
30 days, 6 months and 12 months
Procedure success
Time Frame: 30 days, 6 months and 12 months
30 days, 6 months and 12 months
Acute Device Performance
Time Frame: Index procedure
Index procedure
In hospital, 30-day, 6-month, 12-month MACE
Time Frame: 30-day, 6-month, 12-month
30-day, 6-month, 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Conor Medsystems

Investigators

  • Principal Investigator: Christophe Dubois, M.D., UH Gasthuisberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 15, 2007

First Submitted That Met QC Criteria

January 15, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

October 24, 2008

Last Update Submitted That Met QC Criteria

October 23, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The PreCiSE Trial: CP-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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