MIDCAB Versus DES in Proximal LAD Lesions

June 22, 2018 updated by: University of Leipzig

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • University of Leipzig - Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MIDCAB Surgery
Procedure: Stenting and minimally invasive bypass surgery
Experimental: PCI with drug-eluting stent
PCI with DES
Procedure: PCI with DES
PCI with DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cost-effectiveness
Time Frame: 12 months
12 months
Perioperative complications
Time Frame: 30 days
30 days
CCS-Classification
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Cordis Medizinische Apparate GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

March 3, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 22, 2018

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-Thiele

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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