MIDCAB Versus DES in Proximal LAD Lesions - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

July 7, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Major adverse cardiac events

Change History

Complete list of historical versions of study NCT00299429 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Perioperative complications
CCS-Classification
cost-effectiveness

Descriptive Information

Brief Title ^ICMJE

MIDCAB Versus DES in Proximal LAD Lesions

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Procedure: Stenting and minimally invasive bypass surgery

Study Arms / Comparison Groups

Publications *

Thiele H, Neumann-Schniedewind P, Jacobs S, Boudriot E, Walther T, Mohr FW, Schuler G, Falk V. Randomized comparison of minimally invasive direct coronary artery bypass surgery versus sirolimus-eluting stenting in isolated proximal left anterior descending coronary artery stenosis. J Am Coll Cardiol. 2009 Jun 23;53(25):2324-31.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00299429

Responsible Party

Dr. Holger Thiele, University of Leipzig - Heart Center

Study ID Numbers ^ICMJE

2-Thiele

Study Sponsor ^ICMJE

University of Leipzig

Collaborators ^ICMJE

Cordis Medizinische Apparate GmbH

Investigators ^ICMJE

Principal Investigator:

Holger Thiele, MD

University of Leipzig

Information Provided By

University of Leipzig

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP