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MIDCAB Versus DES in Proximal LAD Lesions

This study has been completed.
Sponsor:
Collaborator:
Cordis Medizinische Apparate GmbH
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00299429
First received: September 9, 2005
Last updated: July 7, 2008
Last verified: March 2007
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Procedure: Stenting and minimally invasive bypass surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perioperative complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • CCS-Classification [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: January 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional 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
Study First Received: September 9, 2005
Last Updated: July 7, 2008
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 23, 2013