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MIDCAB Versus DES in Proximal LAD Lesions

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Stenting and minimally invasive bypass surgery
PCI with DES
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Stent, drug-eluting stent, Minimally invasive bypass surgery, left anterior descending

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Leipzig - Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MIDCAB Surgery

PCI with drug-eluting stent

Arm Description

MIDCAB Surgery

PCI with DES

Outcomes

Primary Outcome Measures

Major adverse cardiac events

Secondary Outcome Measures

Perioperative complications
CCS-Classification
cost-effectiveness

Full Information

First Posted
September 9, 2005
Last Updated
June 22, 2018
Sponsor
University of Leipzig
Collaborators
Cordis Medizinische Apparate GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00299429
Brief Title
MIDCAB Versus DES in Proximal LAD Lesions
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leipzig
Collaborators
Cordis Medizinische Apparate GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Stent, drug-eluting stent, Minimally invasive bypass surgery, left anterior descending

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIDCAB Surgery
Arm Type
Active Comparator
Arm Description
MIDCAB Surgery
Arm Title
PCI with drug-eluting stent
Arm Type
Experimental
Arm Description
PCI with DES
Intervention Type
Procedure
Intervention Name(s)
Stenting and minimally invasive bypass surgery
Intervention Type
Procedure
Intervention Name(s)
PCI with DES
Intervention Description
PCI with DES
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Perioperative complications
Time Frame
30 days
Title
CCS-Classification
Time Frame
12 months
Title
cost-effectiveness
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25499302
Citation
Blazek S, Rossbach C, Borger MA, Fuernau G, Desch S, Eitel I, Stiermaier T, Lurz P, Holzhey D, Schuler G, Mohr FW, Thiele H. Comparison of sirolimus-eluting stenting with minimally invasive bypass surgery for stenosis of the left anterior descending coronary artery: 7-year follow-up of a randomized trial. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):30-8. doi: 10.1016/j.jcin.2014.08.006. Epub 2014 Dec 10.
Results Reference
derived
PubMed Identifier
19539141
Citation
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. doi: 10.1016/j.jacc.2009.03.032.
Results Reference
derived

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MIDCAB Versus DES in Proximal LAD Lesions

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