MIDCAB Versus DES in Proximal LAD Lesions

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299429
• Other study ID #: 2-Thiele
• Status: Completed
• Phase: N/A
• Start date: January 2003
• Est. completion date: July 2008

Study information

• Verified date: March 2007
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Stenting and minimally invasive bypass surgery

• PCI with DES
PCI with DES

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Cordis Medizinische Apparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events		12 months
Secondary	Perioperative complications		30 days
Secondary	CCS-Classification		12 months
Secondary	cost-effectiveness		12 months