NCT00299429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 26, 2018

Status Verified

March 1, 2007

Enrollment Period

5.5 years

First QC Date

September 9, 2005

Last Update Submit

June 22, 2018

Conditions

Coronary Artery Disease

Keywords

Stentdrug-eluting stentMinimally invasive bypass surgeryleft anterior descending

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    12 months

Secondary Outcomes (3)

  • Perioperative complications

    30 days

  • CCS-Classification

    12 months

  • cost-effectiveness

    12 months

Study Arms (2)

MIDCAB Surgery

ACTIVE COMPARATOR

MIDCAB Surgery

Procedure: Stenting and minimally invasive bypass surgery

PCI with drug-eluting stent

EXPERIMENTAL

PCI with DES

Procedure: PCI with DES

Interventions

Stenting and minimally invasive bypass surgeryPROCEDURE
MIDCAB Surgery
PCI with DESPROCEDURE

PCI with DES

PCI with drug-eluting stent

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Informed consent of the patient.
  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

Related Publications (2)

  • 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.

    PMID: 25499302DERIVED

  • 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.

    PMID: 19539141DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Holger Thiele, MD

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

March 6, 2006

Study Start

January 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 26, 2018

Record last verified: 2007-03

Locations

DE(1)