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

December 1, 2013 updated by: Marian Zembala, Silesian Centre for Heart Diseases

Prospective Randomised Pilot Study Evaluating the Safety and Efficacy 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zabrze, Poland, 41-800
        • Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
      • Zabrze, Poland, 41-800
        • Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hybrid revascularization
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
ACTIVE_COMPARATOR: Coronary Artery Bypass Grafting
Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments
Time Frame: 1 year
1 year
Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2
Time Frame: 1 year
1 year
Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marian Zembala, PhD, Silesian Center for Heart Disease
  • Study Chair: Mariusz Gasior, PhD, Silesian Center for Heart Disease

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (ESTIMATE)

December 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 1, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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