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Completed

NCT Number: NCT01035567

Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease

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.

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Key information

Conditions

Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischaemia Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease, Zabrze, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybrid revascularization

Procedure

First stage: implantation of the internal mammary artery into LAD in MIDCAB/TECAB procedure Second stage: PCI with drug eluting stents in other coronary arteries qualified for revascularization within 36 hours after surgery

Coronary artery bypass grafting

Procedure

Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.

Primary outcomes

  1. Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding.

    Time frame: 1 year

Secondary outcomes

  1. Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments

    Time frame: 1 year

  2. Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2

    Time frame: 1 year

  3. Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Silesian Centre for Heart Diseases

Other

Collaborators

  • Ministry of Science and Higher Education, Poland

Registry information

Official study title

Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease

Acronym: POL-MIDES

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 18, 2009
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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