Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease (POL-MIDES)

S

Silesian Centre for Heart Diseases

Status and phase

Completed
Phase 3
Phase 2

Conditions

Coronary Artery Disease
Coronary Disease
Myocardial Ischaemia
Heart Disease

Treatments

Procedure: Hybrid revascularization
Procedure: Coronary Artery Bypass Grafting

Study type

Interventional

Funder types

Other

Identifiers

NCT01035567
N R13 008406/2009

Details and patient eligibility

About

The purpose of the study is to assess the safety and efficacy of hybrid revascularization in comparison with coronary artery bypass grafting among patients with multivessel coronary artery disease.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 or more
  • Angiographically confirmed multivessel CAD with involved LAD and critical (>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG
  • Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia
  • Patient is willing to comply with all follow-up visits
  • Patient signed an Informed Consent

Exclusion criteria

  • Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment
  • Prior surgery with the opening of pericardium or pleura
  • Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects
  • Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation
  • One or more chronic total occlusions in major coronary territories
  • Left main stenosis (at least 50% diameter stenosis)
  • Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization
  • Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
  • Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition
  • Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
  • Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
  • Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease
  • Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age
  • Concurrent enrollment in another clinical trial
  • Patient inaccessible for follow-up visits required by protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Hybrid revascularization
Active Comparator group
Treatment:
Procedure: Hybrid revascularization
Coronary Artery Bypass Grafting
Active Comparator group
Treatment:
Procedure: Coronary Artery Bypass Grafting

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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