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MIDCAB Versus DES in Proximal LAD Lesions

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ClinicalTrials.gov Identifier: NCT00299429
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : July 8, 2008
Sponsor:
Collaborator:
Cordis Medizinische Apparate GmbH
Information provided by:
University of Leipzig

Brief Summary:
Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Stenting and minimally invasive bypass surgery Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Comparison of Minimally Invasive Direct Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention With Drug-Eluting Stents in Patients With Proximal Stenosis of the Left Anterior Descending Coronary Artery
Study Start Date : January 2003
Primary Completion Date : July 2008
Study Completion Date : July 2008



Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Perioperative complications [ Time Frame: 30 days ]
  2. CCS-Classification [ Time Frame: 12 months ]
  3. cost-effectiveness [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Single-vessel disease of the proximal LAD with a stenosis > 50% (multivessel disease only if further coronary vessel stenoses do not require treatment)
  2. Patients with angina pectoris (CCS 1-4)
  3. Asymptomatic patients if clear signs of ischemia in the segments supplied by the LAD as assessed by bicycle ergometry or treadmill and/or scintigraphically and/or stress echo
  4. Patients for whom both methods of treatment are equally possible
  5. Consensus between the cardiac surgeon and the cardiologist that both inclusion and exclusion criteria are met in the selected case
  6. Informed consent of the patient.

Exclusion Criteria:

  1. Patients < 18 years
  2. Pregnancy
  3. Previous coronary artery bypass surgery
  4. Concomitant diseases that lead to a greater risk for each of the treatment strategies
  5. Significant peripheral arterial occlusive disease
  6. Concomitant disease with limited life expectancy (e.g. malignant tumours that have not been curatively treated)
  7. Objective follow-up examination not possible due to physical or mental handicap
  8. Participation in another study.

Angiographical exclusion criteria:

  1. Left main stem stenosis
  2. Multivessel disease for which surgical or interventional therapy on other vessel areas is required.
  3. Diagonal/septal branch > 1.5 mm, which might be compromised by a stent
  4. Need for acute intervention (e.g. acute myocardial infarction)
  5. Total occlusion of the LAD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299429


Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Cordis Medizinische Apparate GmbH
Investigators
Principal Investigator: Holger Thiele, MD Heartcenter Leipzig GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Holger Thiele, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier: NCT00299429     History of Changes
Other Study ID Numbers: 2-Thiele
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: July 8, 2008
Last Verified: March 2007

Keywords provided by University of Leipzig:
Stent
drug-eluting stent
Minimally invasive bypass surgery
left anterior descending

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases