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Coronary Artery StenosisPhase 4NCT00375063

Study of Unprotected Left Main Stenting Versus Bypass Surgery (LE MANS Study)

A Phase 4 study testing Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in people with Coronary Artery Stenosis and Myocardial Revascularization, run by Ministry of Science and Higher Education, Poland at 5 sites in 2 countries.

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

Unprotected left main coronary artery (ULMCA) stenting, offering restoration of a native flow to left coronary artery, is the subject of intense investigations as a potential alternative to bypass surgery. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting
Type of treatment
Surgery or procedure
How many people
130 participants
Where
5 sitesin 2 countries
Study dates
Jan 2001to Dec 2005
Phase
Phase 4
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients' age 18 to 80
  • Significant LM stenosis (>50%)
  • The target vessel reference diameter 2.5mm.
  • Concomitant multivessel disease suitable for PCI is allowed.
  • The patient is an acceptable candidate for coronary artery bypass surgery.
  • The patient agreement for 6 month follow-up cardiac catheterization, which will include left ventricular angiogram.
  • The patient written informed consent.

Who cannot join

  • An allergy or contraindication to aspirin, ticlopidine or Clopidogrel.
  • Presence of diffuse, significant (>++) calcifications in LM
  • Left ventricular ejection fraction < 35%
  • History of bleeding diathesis or coagulopathy.
  • Any previous PCI or CABG surgery
  • Acute MI within 48 hours, cardiogenic shock.
Show all 12Show fewer
  • Bail-out stenting of dissected LM during complicated PCI.
  • The patient suffered a stroke or transient ischemic neurological attack (TIA) within 3 months.
  • Chronic renal insufficiency.
  • Positive pregnancy test.
  • Any disease that may shorten the life expectancy of the patient.
  • The patient is currently participating in another research study.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Poland3 sites

  • Silesian Medical School 1-st Department of Cardiosurgery

    Katowice, Silesian Voivodeship, 40-635

  • Silesian Medical School 3-rd Department of Cardiology, Coronary Care Unit

    Katowice, Silesian Voivodeship, 40-635

  • Jagiellonian University

    Krakow, Lesser Poland Voivodeship, 31-147

Other trials in Poland

United States2 sites

  • Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Bryn Mawr, PA, USA and Thomas Jefferson University, Philadelphia

    Bryn Mawr, Pennsylvania, 19010

  • San Antonio Endovascular and Heart Institute and University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78248

Other trials in United States

About this study

Official title: Prospective Randomized Study of Unprotected Left Main Stenting Versus Bypass Surgery

Unprotected left main coronary artery (ULMCA) stenting, offering restoration of a native flow to left coronary artery, is the subject of intense investigations as a potential alternative to bypass surgery. The purpose of the study is to compare the short and long term results of unprotected left main stenting with coronary artery bypass surgery.

Read the detailed description

The natural history and the results of pharmacological treatment in patients with severe narrowing of left main coronary artery show very poor prognosis (5 year survival less than 50%).

There is general agreement that surgical treatment improves 5 year survival in patients with left main coronary artery obstruction 3, however long term survival rate (15 year follow-up) is low in both groups (37% and 27% respectively in surgical and medical group). Median survival was longer in surgical group in general population (13.3 vs 6.6 years) , but there was no significant difference in patients with normal LV ejection fraction (14.7 vs 15 years).

With the advent of coronary stenting encouraging results were reported by several authors. There was high success rate 98-100% for elective procedures and in these series the mortality (for protected and non-protected left main) ranged from 0 to 3.4 %, and 6 month event free survival rate was 70-80%. Restenosis rate in stented LM varied from 10-22% for proximal LM to 40% for distal LM. Final minimal luminal area >=7mm2 post procedure, assessed by IVUS, predicted low restenosis rate of 7%, while the area below <7mm2 was connected with restenosis of 50%. Our and other experience showed that left main in-stent restenosis can be treated successfully with another percutaneous intervention (including endarterectomy and balloon angioplasty) as well as by surgical revascularization.

Six and 12-month survival rate depended on the LV function. Patients with LVEF>40% had in-hospital event free survival of 98% and 9-month event free survival of 86%, whereas patients with LVEF <40% had in-hospital and 9 month event-free survival of 67 and 22% respectively. Additionally, in patients presented with acute myocardial infarction or bail-out procedures, early and late results of LM stenting were not as good as for elective cases.

Our previously presented promising results of left main stenting is mainly related to proper technique of LM stenting (short inflations within LM, careful guiding catheter manipulation, stent selection), as well as very cautiously designed follow-up (every month visit for first six month, routine coronary angiography within 3-6 months after procedure). This initial experience gives us the backgrounds for a larger prospective randomized trial comparing elective surgical revascularisation and percutaneous intervention in patients with LM coronary artery disease. It is our impression that design and the delivery system of the new generation stent is uniquely suited to safely treat this difficult subset of patients. At the present time we would limit the study to the discrete lesions in proximal (ostial and mid) left main with reference luminal diameter >=3 mm. Based on published results of stenting under IVUS examination for such a lesion we estimate the restenosis rate to be well below 10%. As we expect, the survival and complication rate within one year in both group will be similar. Therefore our main concern is weather both treatment strategies will offer the same prevention of LV function, as well as improvement of functional capacity and coronary reserve in both groups in a period of 2-3 years.

Being tested
Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting
Keywords
left main stenosis, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting
Medical subject headings
Coronary Stenosis, Myocardial Ischemia

What participants receive

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

  • Percutaneous Coronary InterventionProcedure or surgery

  • Coronary Artery Bypass GraftingProcedure or surgery

What is being measured

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

  1. LV function assessed by 2D echocardiography

  2. exercise tolerance measured with ECG treadmill stress testing

  3. angina severity according to CCS classification 12 months after the index intervention

Secondary outcomes (5)

  1. 30 day and one year major adverse events (MAE)

  2. 30 day and one year major acute cardiovascular events (MACE)

  3. length of hospitalization

  4. one year and total survival and freedom from MACE

  5. one year target vessel failure (TVF).

Timeline

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

  1. First posted12 Sep 2006 (estimated)
  2. Study startJan 2001
  3. Study completionDec 2005

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00375063
Sponsor's protocol ID
6 P05B 132 21
Status last verified
Sep 2006
First submitted
11 Sep 2006
Last updated
12 Sep 2006
Results posted
No

Publications

  • Chieffo A, Colombo A. Treatment of unprotected left main coronary artery disease with drug-eluting stents: is it time for a randomized trial? Nat Clin Pract Cardiovasc Med. 2005 Aug;2(8):396-400. doi: 10.1038/ncpcardio0272.

    PubMed 16119701

  • Chieffo A, Stankovic G, Bonizzoni E, Tsagalou E, Iakovou I, Montorfano M, Airoldi F, Michev I, Sangiorgi MG, Carlino M, Vitrella G, Colombo A. Early and mid-term results of drug-eluting stent implantation in unprotected left main. Circulation. 2005 Feb 15;111(6):791-5. doi: 10.1161/01.CIR.0000155256.88940.F8. Epub 2005 Feb 7.

    PubMed 15699254

  • Park SJ, Kim YH, Lee BK, Lee SW, Lee CW, Hong MK, Kim JJ, Mintz GS, Park SW. Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis: comparison with bare metal stent implantation. J Am Coll Cardiol. 2005 Feb 1;45(3):351-6. doi: 10.1016/j.jacc.2004.10.039.

    PubMed 15680711

  • Valgimigli M, van Mieghem CA, Ong AT, Aoki J, Granillo GA, McFadden EP, Kappetein AP, de Feyter PJ, Smits PC, Regar E, Van der Giessen WJ, Sianos G, de Jaegere P, Van Domburg RT, Serruys PW. Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH). Circulation. 2005 Mar 22;111(11):1383-9. doi: 10.1161/01.CIR.0000158486.20865.8B.

    PubMed 15781749

  • Peszek-Przybyla E, Buszman P, Bialkowska B, Zurakowski L, Banasiewicz-Szkrobka I, Debinski M, Tendera M. Stent implantation for the unprotected left main coronary artery. The long-term outcome of 62 patients. Kardiol Pol. 2006 Jan;64(1):1-6; discussion 7.

    PubMed 16444619

  • Buszman PE, Kiesz SR, Bochenek A, Peszek-Przybyla E, Szkrobka I, Debinski M, Bialkowska B, Dudek D, Gruszka A, Zurakowski A, Milewski K, Wilczynski M, Rzeszutko L, Buszman P, Szymszal J, Martin JL, Tendera M. Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization. J Am Coll Cardiol. 2008 Feb 5;51(5):538-45. doi: 10.1016/j.jacc.2007.09.054.

    PubMed 18237682

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in people with Coronary Artery Stenosis and Myocardial Revascularization, run by Ministry of Science and Higher Education, Poland at 5 sites in 2 countries.

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 7 inclusion and 12 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 12 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Poland, United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

LV function assessed by 2D echocardiography. The study lists 3 primary outcomes in all. 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 NCT00375063, which also lists 6 linked publications.

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 12 Sep 2006.

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