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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Marian Zembala, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier:
NCT01035567
First received: December 16, 2009
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Heart Disease
Myocardial Ischaemia
Coronary Disease
Coronary Artery Disease
Procedure: Hybrid revascularization
Procedure: Coronary Artery Bypass Grafting
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Silesian Centre for Heart Diseases:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: November 2009
Study Completion Date: October 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hybrid revascularization Procedure: 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 Procedure: Coronary Artery Bypass Grafting
Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035567

Locations
Poland
Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease
Zabrze, Poland, 41-800
Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
Zabrze, Poland, 41-800
Sponsors and Collaborators
Silesian Centre for Heart Diseases
Ministry of Science and Higher Education, Poland
Investigators
Principal Investigator: Marian Zembala, PhD Silesian Center for Heart Disease
Study Chair: Mariusz Gasior, PhD Silesian Center for Heart Disease
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marian Zembala, MD, PhD, Head of the Cardiosurgery and Transplantology Department, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier: NCT01035567     History of Changes
Other Study ID Numbers: N R13 008406/2009
Study First Received: December 16, 2009
Last Updated: December 1, 2013
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Silesian Centre for Heart Diseases:
Multivessel coronary artery disease
Hybrid revascularization
Coronary Artery Bypass Grafting
Percutaneous Coronary Interventions
Drug eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014