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Coronary ArteriosclerosisPhase 3NCT00300157

Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

A Phase 3 study testing Percutaneous coronary intervention with Taxus stent in people with Coronary Arteriosclerosis, run by French Cardiology Society at 26 sites in France.

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

The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Arteriosclerosis
What is being tested?
Percutaneous coronary intervention with Taxus stent
Type of treatment
Medical device
How many people
155 participants
Where
26 sitesFrance
Study dates
Dec 2005to Jan 2010
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

  • The patient must be > or = 18 years of age
  • Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee
  • Aspirin + Clopidogrel > or = 12 hours before percutaneous coronary intervention (PCI)
  • Documented evidence of ischemic heart disease (clinical,biological or ECG) with unprotected left main coronary artery stenosis > or = 50% associated to other coronary lesions or not responsible of stable or unstable coronary syndrome above 48 hours
  • The target reference vessel diameter must be > or = 2.5 mm
  • Unprotected left main coronary artery disease eligible by coronary stenting

Who cannot join

  • Restenosis lesion in left main coronary artery
  • Known allergies to the following: aspirin, clopidogrel,ticlopidine,contrast agent or drug similar to paclitaxel
  • Acute coronary syndrome < 48 hours
  • Impaired renal function (creatinine > 180 ùmol/l) at the time of treatment
  • Life expectancy less than 36 months
  • Female of childbearing potential without reliable birth control
  • Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

France26 sites

  • Polyclinique du Parc Rambot

    Aix-en-Provence, 13100

  • Clinique Rhône Durance

    Avignon, 84082

  • Clinique Saint Augustin

    Bordeaux, 33000

  • Chu Brest

    Brest, 29609

  • CHU CAEN

    Caen, 14033

  • Hôpital Cardiologique

    Lille, 59037

  • Clinique du Tonkin

    Lyon, 69100

  • Unité Cardio-Vasculaire

    Marseille, 13009

  • CHU NORD

    Marseille, 13326

  • Institut Hospitalier Jacques Cartier-ICPS

    Massy, 91300

  • Hôpital Bon Secours

    Metz, 57000

  • Clinique du Millénaire

    Montpellier, 34960

  • Nouvelles Cliniques Nantaises

    Nantes, 44000

  • Hôpital privé Les Franciscaines

    Nîmes, 30000

  • CHU Caremeau

    Nîmes, 30029

  • Hôpital COCHIN

    Paris, 75014

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Groupe Hospitalier La Pitié-Salpetrière

    Paris, 75651

  • CHU Pontchaillou

    Rennes, 35033

  • Clinique Saint Hilaire

    Rouen, 76000

  • Hôpital Charles Nicolle

    Rouen, 76031

  • Centre Cardiologique du Nord

    Saint-Denis, 93200

  • Institut Arnaud Tzanck

    Saint-Laurent-du-Var, 06700

  • CHU Toulouse Rangueil

    Toulouse, 31059

  • Clinique Pasteur

    Toulouse, 31100

  • Clinique Saint Gatien

    Tours, 37042

Other trials in France

About this study

Official title: French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not

The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.

Read the detailed description

Coronary artery bypass graft is the reference treatment of left main coronary artery disease. With the advancements of technology and particularly drug-eluting stents, in-stent restenosis has dramatically decreased and now it is possible to extend indications of complexes lesions such as left main coronary artery stenoses. In these particular situations,some centers performed percutaneous coronary angioplasty (PCI) with drug-eluting stents with acceptable results in terms of safety and efficacy. However, these procedures are performed at isolated sites and are not evaluated in multicenter trial.The aim of this study is to assess the safety and efficacy of this PCI with Taxus-stent in a french multicenter trial and to evaluate clinical and angiographic outcome of these patients at long-term follow-up.

Being tested
Percutaneous coronary intervention with Taxus stent
Keywords
Left main coronary artery stenosis, stent, Taxus, Unprotected left main coronary artery disease, Percutaneous coronary intervention with Taxus stent
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Percutaneous coronary intervention with Taxus stentDevice

What is being measured

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

  1. Coronarography

    Measured: 9 months

Secondary outcomes (1)

  1. Major cardio-vascular events

    Measured: 1, 18 and 36 months

Timeline

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

  1. First posted8 Mar 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionJan 2010
  4. Study completionJan 2010

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
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00300157
Sponsor's protocol ID
2004-06
Status last verified
Jan 2011
First submitted
7 Mar 2006
Last updated
4 Jan 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Percutaneous coronary intervention with Taxus stent in people with Coronary Arteriosclerosis, run by French Cardiology Society at 26 sites in France.

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 6 inclusion and 7 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 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France. 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?

Coronarography (time frame: 9 months). 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 NCT00300157.

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 4 Jan 2011.

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