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OpenTrials
Completed

NCT Number: NCT00299429

MIDCAB Versus DES in Proximal LAD Lesions

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single-vessel disease of the proximal LAD with a stenosis > 50% (multivessel disease only if further coronary vessel stenoses do not require treatment)
  • Patients with angina pectoris (CCS 1-4)
  • 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
  • Patients for whom both methods of treatment are equally possible
  • Consensus between the cardiac surgeon and the cardiologist that both inclusion and exclusion criteria are met in the selected case
  • Informed consent of the patient.

Exclusion criteria

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

Angiographical exclusion criteria:

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

Treatment and study plan

Stenting and minimally invasive bypass surgery

Procedure

PCI with DES

Procedure

PCI with DES

Primary outcomes

  1. Major adverse cardiac events

    Time frame: 12 months

Secondary outcomes

  1. Perioperative complications

    Time frame: 30 days

  2. CCS-Classification

    Time frame: 12 months

  3. cost-effectiveness

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Cordis Medizinische Apparate GmbH

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Mar 6, 2006
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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