MIDCAB Versus DES in Proximal LAD Lesions

NCT ID: NCT00299429

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-07-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MIDCAB Surgery

MIDCAB Surgery

Group Type ACTIVE_COMPARATOR

Stenting and minimally invasive bypass surgery

Intervention Type PROCEDURE

PCI with drug-eluting stent

PCI with DES

Group Type EXPERIMENTAL

PCI with DES

Intervention Type PROCEDURE

PCI with DES

Interventions

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Stenting and minimally invasive bypass surgery

Intervention Type PROCEDURE

PCI with DES

PCI with DES

Intervention Type PROCEDURE

Eligibility Criteria

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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

Exclusion Criteria

6. Informed consent of the patient.


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.


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Medizinische Apparate GmbH

OTHER

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holger Thiele, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Locations

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University of Leipzig - Heart Center

Leipzig, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25499302 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19539141 (View on PubMed)

Other Identifiers

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2-Thiele

Identifier Type: -

Identifier Source: org_study_id

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