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Coronary DiseasePhase 3NCT00422435

CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

A Phase 3 study testing CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter in people with Coronary Disease, run by Conor Medsystems at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteBelgium
Study dates
Jan 2007to May 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UH Gasthuisberg

    Leuven, 3000

Other trials in Belgium

About this study

Official title: 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.

Read the detailed description

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

Being tested
CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter
Keywords
Percutaneous coronary intervention (PCI), Drug eluting stent (DES)
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheterDevice

    Paclitaxel-Eluting Coronary Stent

Study groups in NCT00422435
Study groupRoleWhat they receive
Drug eluting stentExperimentalCoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter
Receives: Device: CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device Success

    Measured: At procedure or hospital discharge

Secondary outcomes (4)

  1. Lesion success

    Measured: 30 days, 6 months and 12 months

  2. Procedure success

    Measured: 30 days, 6 months and 12 months

  3. Acute Device Performance

    Measured: Index procedure

  4. In hospital, 30-day, 6-month, 12-month MACE

    Measured: 30-day, 6-month, 12-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionMay 2007
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00422435
Sponsor's protocol ID
The PreCiSE Trial: CP-03
Status last verified
Oct 2008
First submitted
15 Jan 2007
Last updated
24 Oct 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter in people with Coronary Disease, run by Conor Medsystems at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Success (time frame: At procedure or hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00422435.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2008.

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